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PT. SYSMEX INDONESIA

Authorized Representative in Indonesia

Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
422 Products Represented
70 Manufacturers
Total Products
422
Manufacturers
70
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
60 products
14.2%
Kelas Resiko : B
318 products
75.4%
Kelas Resiko : C
36 products
8.5%
Kelas Resiko : D
8 products
1.9%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (422)
Complete portfolio registered with BPOM

SYSMEX Automated Blood Coagulation Analyzer CN-6000

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2025

XN CAL PF

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2025

SULFOLYSER

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2025

POCH-PACK L PPL-200A

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 2, 2025

XN-CHECK L2

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

XN-CHECK™ L3

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

EIGHTCHECK-3WP-H

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

SYSMEX CELLSHEATH

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

SYSMEX CD4% easy count kit

Manufacturer:

EXBIO PRAHA, A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

SYSMEX Ca Cal S

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2024

JEOL CA-21391 RAMINI RACK HANDLER

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2024

DiaSys TruLab L Level 2

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

DiaSys Trucal CRP 150

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

DIASYS TruCal CRP high

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

SYSMEX-BX Series Iron FS Ferene

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

JEOL Cuvette Conditioner EX

Manufacturer:

JEOL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 17, 2024

JEOL Reagent Probe Wash S

Manufacturer:

JEOL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2024

JEOL Cuvette Wash Solution 7

Manufacturer:

JEOL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2024

JEOL Reagent Probe Wash 2

Manufacturer:

JEOL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 11, 2024

BIOMAJESTY™ Potassium Electrode

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2024

JEOL Reagent Probe Wash 1

Manufacturer:

JEOL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 11, 2024

SYSMEX CD4 easy count kit

Manufacturer:

EXBIO PRAHA, A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

JEOL Reference Electrode

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2024

DIASYS TruCal Ferritin

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2024

JEOL Reagent Probe Wash K

Manufacturer:

JEOL LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 30, 2024

DIASYS TruLab Albumin U/ CSF Level 2

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

BM Test HbA1c Control (High dan Low)

Manufacturer:

SEKISUI MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

BIOMAJESTY ISE Serum Standard Set (NA)

Manufacturer:

A&T CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2024

BIOMAJESTY Internal Standard

Manufacturer:

A&T CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2024

BIOMAJESTY ISE Buffer (IS)

Manufacturer:

A&T CORPORATION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2024

BIOMAJESTY ISE Urine Standard Set

Manufacturer:

A&T CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2024

BIOMAJESTY ISE Detergent Solution

Manufacturer:

A&T CORP.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2024

DIASYS TruCal IgE

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2024

BM Test HbA1c Calibrator (1 dan 2)

Manufacturer:

SEKISUI MEDICAL CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

XN-L CHECK L1

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

BIOMAJESTY™ Sodium Electrode

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

BIOMAJESTY™ Chloride Electrode

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

BM Test HbA1c Reagent 2

Manufacturer:

SEKISUI MEDICAL CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

JEOL JCA-BM6010/C AUTOMATIC ANALYZER

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2024

BM Test HbA1c Diluent

Manufacturer:

SEKISUI MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2024

EIGHTCHECK-3WP-N

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

BM Test HbA1c Reagent 1

Manufacturer:

SEKISUI MEDICAL CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

UF-CELLSHEATH

Manufacturer:

SYSMEX ASIA PACIFIC PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2024

SYSMEX Automated Blood Coagulation Analyzer CN-3000

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 26, 2024

SYSMEX XQ-320 XQ Series Automated Hematology Analyzer and Accessories

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

UF-CELLPACK SF

Manufacturer:

SYSMEX ASIA PACIFIC PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

HISCL Anti HCV II Assay Kit

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 4, 2024

SYSMEX CA CLEAN I CL I

Manufacturer:

SYSMEX CORPORATION (ONO FACTORY)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 7, 2024

SYSMEX UC-3500 Fully Automated Urine Chemistry Analyzer and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

SYSMEX Fully Automated Urine Particle Analyzer UF-4000 and Accessoris

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

SYSMEX CA CLEAN II

Manufacturer:

SYSMEX CORPORATION Ono Factory

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 3, 2024

TRULAB Bicarbonate

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

BIOPHEN Rivaroxaban Plasma Calibrator

Manufacturer:

HYPHEN BIOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

BIOPHEN Rivaroxaban Control Plasma

Manufacturer:

HYPHEN BIOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2024

HISCL CA125 II Assay Kit

Manufacturer:

PRICES LABORATORIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

HISCL CA125 II Calibrator

Manufacturer:

PRICES LABORATORIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

SYSMEX Lysercell WDF II

Manufacturer:

SYSMEX ASIA PACIFIC, PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

SYSMEX Integrated Urine Analyzer UN-2000-011

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2024

SYSMEX Integrated Urine Analyzer UN-2000-011a (Bundling: UC-3500 + UF-4000)

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2024

INNOVANCE Free PS Ag

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

RAL DIAGNOSTICS SP Cleaning Solution for SP Automated Systems

Manufacturer:

RAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 19, 2024

RAL DIAGNOSTICS Wright Giemsa Solution for SP Automated Systems

Manufacturer:

RAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 7, 2024

RAL DIAGNOSTICS pH=6.8 Buffer Solution for SP Automated Systems

Manufacturer:

RAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 4, 2024

SYSMEX XR-10 Automated Hematology Analyzer XR Series and Accessories

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2024

SYSMEX Automated Hematology Analyzer XN-3000

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2024

SYSMEX XR-20 Automated Hematology Analyzer XR Series and Accessories

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2024

SYSMEX Automated Hematology Analyzer XN-2000

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2024

RAL DIAGNOSTICS Wright Solution for SP Automated Systems

Manufacturer:

RAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 9, 2024

RAL DIAGNOSTICS Giemsa Solution for SP Automated Systems

Manufacturer:

RAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 3, 2024

RAL DIAGNOSTICS pH=7.0 Buffer Solution for SP Automated Systems

Manufacturer:

RAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 3, 2024

RAL DIAGNOSTICS May Grunwald Solution for SP Automated Systems

Manufacturer:

RAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 14, 2023

UC-CONTROL™

Manufacturer:

CLINIQA CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

HISCL™ HBsAg Assay Kit

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 24, 2023

SIEMENS Berichrom Factor XIII

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

SYSMEX Control Viratrol

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

HISCL HBsAg Calibrator

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

SYSMEX Sulfolyser SLS

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

DADE ACTIN FS Activated PTT Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

HISCL Substrate Reagent Set

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

DADE ACTIN FSL Activated PTT Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

HISCL Diluent

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

HISCL Washing Solution

Manufacturer:

SYSMEX CORPORATION ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

HISCL Line Washing Solution

Manufacturer:

SYSMEX CORPORATION ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

HISCL Probe Washing Solution

Manufacturer:

SYSMEX CORPORATION ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

SYSMEX HBV IMMUNOASSAY CONTROL

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

HISCL Cardiac Marker Control

Manufacturer:

SYSMEX CORPORATION SEISHIN FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 30, 2023

SYSMEX Automated Hematology Analyzer XN-1500

Manufacturer:

SYSMEX CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

SYSMEX RET-SEARCH (II) RED-700A

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 15, 2023

SIEMENS Berichrom Protein C

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2023

FLUOROCELL PLT

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY, JAPAN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2023

CELLCLEAN AUTO

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2023

FLUOROCELL WNR

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 11, 2023

STROMATOLYSER-4DS

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 11, 2023

SYSMEX CELLCLEAN CL-50

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 11, 2023

SYSMEX Stromatolyser™ -NR Lysing Reagen

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2023

STROMATOLYSER-WH

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

SYSMEX CELLCHECK- 400 CC-12

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 6, 2023

CN-COAGWASHER

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2023

FLUOROCELL WPC

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 29, 2023

SYSMEX Lysercell ™ WNR

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

BERICHROM Antithrombin III (A)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2023

SYSMEX Lysercell WPC

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2023

BIOPHEN™ DiXaI

Manufacturer:

HYPHEN BIOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2023

CELLPACK™ DCL

Manufacturer:

SYSMEX CORPORATION ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2023

CELLPACK DST

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2023

DIASYS Creatinine PAP FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

DIASYS Cholesterol FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

DIASYS Calcium AS FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

SYSMEX Automated Immunoassay System HISCL-800 and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

SYSMEX Automated Immunoassay System HISCL-5000 and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

HISCL HBeAg Calibrator

Manufacturer:

JAPAN LYOPHILIZATION LABORATORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

XN-L CHECK™ L2

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

XN-L CHECK L3

Manufacturer:

DASH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

XN-L CHECK ™ L1

Manufacturer:

DASH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

SYSMEX Automated Hematology Analyzer XN-L Series, XN-450 and Accessories

Manufacturer:

SYSMEX CORPORATION. (KAKOGAWA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

HISCL CEA Assay Kit

Manufacturer:

PRICES LABORATORIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2023

SYSMEX Automated Hematology Analyzer XN-L Series, XN-450 and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2023

DADE Fibrinogen Determination Reagents

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2023

HISCL Immuno Multi Control

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2023

SYSMEX Automated Hematology Analyzer XN-L Series, XN-550 and Accessories

Manufacturer:

SYSMEX CORPORATION (I-SQUARE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2023

DIASYS Total protein FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2023

DIASYS Triglyceride FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2023

SYSMEX Concentrated Phosphate Buffer for SP pH 7.0

Manufacturer:

SYSMEX CORPORATION (ONO FACTORY)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 27, 2023

HISCL™ Insulin Calibrator

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2023

Concentrated Phosphate Buffer for SP pH 7.2

Manufacturer:

SYSMEX CORPORATION ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 25, 2023

DIASYS Uric acid FS TOOS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2023

HISCL Troponin T hs Calibrator

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2023

DIASYS Lipase DC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2023

DIASYS Glucose GOD FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 21, 2023

SYSMEX Concentrated Phosphate Buffer for SP pH 6.6

Manufacturer:

SYSMEX CORPORATION, Ono Factory

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 20, 2023

DIASYS Urea FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2023

SYSMEX Automated Tube Sorter TS-10 and Accessories

Manufacturer:

SYSMEX RA CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 20, 2023

SYSMEX Concentrated Phosphate Buffer for SP pH 6.8

Manufacturer:

SYSMEX CORPORATION ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 20, 2023

DIASYS Uric acid FS TBHBA

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

DIASYS Phosphate FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

DIASYS Pancreatic amylase CC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

DIASYS Magnesium XL FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

DIASYS Glucose Hexokinase FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 17, 2023

DIASYS Iron FS Ferene

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2023

DIASYS LDH 21 FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2023

DIASYS HDL-c direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2023

DIASYS Gamma-GT FS (Szasz mod./IFCC stand.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2023

RESPONSE Triglyceride FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2023

SYSMEX Automated Hematology Analyzer XN-L Series, XN-350 and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2023

DIASYS LDL-C direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2023

RESPONS Urea FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2023

RESPONS Uric acid FS TOOS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2023

RESPONSE LDH 21 FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2023

HISCL CA15-3 Calibrator

Manufacturer:

JAPAN LYOPHILIZATION LABORATORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 7, 2023

RESPONS LDL-C direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2023

HISCL M2BPGi Control

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

RESPONS Iron FS Ferene

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2023

RESPONS Pancreatic amylase CC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2023

RESPONSE Total FS protein

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2023

HISCL M2BPGi Assay Kit

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

HISCL™ TSH Assay Kit

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

MEDITAPE UC-9A

Manufacturer:

EIKEN CHEMICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2023

RESPONS Glucose Hexokinase FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2023

MEDITAPE UC-11A

Manufacturer:

EIKEN CHEMICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2023

DIASYS Creatinine FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

HISCL FT4 Calibrator

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

DIASYS Bicarbonate FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

DIASYS CK-MB FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

HISCL™ TSH Calibrator

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

DIASYS α-Amylase CC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

DIASYS Bilirubin Auto Direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

DIASYS CK-NAC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2023

DIASYS ALAT (GPT) FS (IFCC mod.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2023

DIASYS Alkaline phosphatase FS IFCC° 37 C

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2023

DIASYS Bilirubin Auto Total FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2023

REVOHEM Collagen

Manufacturer:

HYPHEN BIOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2023

RESPONS Cleaner A

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2023

SYSMEX UF-Control

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2023

RESPONSE Cleaner B

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2023

RESPONS Cholesterol FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2023

CK-MB FS RESPONSE

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

RESPONS CK-NAC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

DIASYS Albumin FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

DIASYS Albumin in Urine/CSF FS (Microalbumin)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

DIASYS ASAT (GOT) FS (IFCC mod.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

DIASYS Cholinesterase FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 1, 2023

RESPONSE Bilirubin Auto Total FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

RESPONS Bilirubin Auto Direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

SYSMEX UF-CELLPACK SF

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

RESPONS Creatinine PAP FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

Respons Calcium P FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

RESPONS Creatinine FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

SYSMEX UF-CELLPACK CR

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

RESPONS Gamma-GT FS (Szasz mod./IFCC stand.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

HISCL HIV Ag + Ab Control

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

HISCL™ FT3 Assay Kit

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

Albumin FS RESPONSE

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

RESPONS ASAT (GOT) FS (IFCC mod.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

RESPONS Alkaline phosphatase FS IFCC 37 °C

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

UF-CELLSHEATH

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

RESPONS ALAT (GPT) FS (IFCC mod.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

SYSMEX UF-CALIBRATOR

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

SYSMEX HISCL HIV Ag+Ab Assay Kit

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 22, 2023

HISCL FT3 Calibrator

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

HISCL ™ FT4 Assay Kit

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

HISCL Anti HCV II Calibrator

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

HISCL HIV Ag+Ab Calibrator

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

HISCL Anti-HCV Assay Kit

Manufacturer:

SYSMEX CORPORATION SEISHIN FACTORY

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 19, 2023

HISCL M2BPGi Calibrator

Manufacturer:

SYSMEX CORPORATION, SEISHIN FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

SYSMEX UF-Fluorocell CR

Manufacturer:

SYSMEX CORPORATION ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 5, 2023

SYSMEX UF-Fluorocell SF

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 5, 2023

FLUOROCELL™ RIGHT

Manufacturer:

SYSMEX CORPORATION, ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 26, 2023

LYSERCELL™ WNR

Manufacturer:

SYSMEX ASIA PACIFIC PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2023

SULFOLYSER

Manufacturer:

SYSMEX ASIA PACIFIC PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2023

DIASYS TruLab HbA1c net Level 2

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2023

pocH-pack D (II)

Manufacturer:

SYSMEX ASIA PACIFIC PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2023

FLUOROCELL WDF

Manufacturer:

SYSMEX CORPORATION ONO FACTORY.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 30, 2023

CELLPACK

Manufacturer:

SYSMEX ASIA PACIFIC PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2023

DiaSys TruLab HbA1c net Level 1

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2023

SYSMEX Lysercell WDF

Manufacturer:

SYSMEX CORPORATION ONO FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2023

SYSMEX CELLPACK DFL

Manufacturer:

SYSMEX CORPORATION ONO FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2023

LYSERCELL ™ WDF

Manufacturer:

SYSMEX ASIA PACIFIC, PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2023

BIOMAJESTY HbA1c net Hemolyzing Solution

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

DIASYS TruCal HbA1c net

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

Diasys HbA1c net FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

SYSMEX BX-Series ASAT (GOT) FS (IFCC mod.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2023

SYSMEX Automated Blood Coagulation Analyzer CS-1600

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2023

SYSMEX Automated Coagulation Analyzer CS-2500 and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 10, 2023

SYSMEX BX-Series Alat (GPT) FS (IFCC mod.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

HEMOCLOT Thrombin Inhibitors

Manufacturer:

HYPHEN BIOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 2, 2023

SYSMEX Wash Solution C-1

Manufacturer:

SYSMEX CORPORATION ONO FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 23, 2023

WASH SOLUTION No.9

Manufacturer:

SYSMEX CORPORATION Ono Factory

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 21, 2023

SYSMEX Wash Solution No.3

Manufacturer:

SYSMEX CORPORATION Ono Factory

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 21, 2023

INNOVANCE D-Dimer

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2022

INNOVANCE Antithrombin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

SYSMEX CD4 easy count kit

Manufacturer:

EXBIO PRAHA, a.s

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2022

SYSMEX CD4% Easy Count Kit

Manufacturer:

EXBIO PRAHA, a.s.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2022

DIASYS TruCal RF

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

CYFLOW Counter

Manufacturer:

SYSMEX PARTEC GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

DADE Thrombin Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2022

SIEMENS Test Thrombin Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2022

DiaSys TruLab Protein Level 1

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

DIASYS TruLab Cystatin C Level 2

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

DiaSys TruLab Protein Level 2

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

DIASYS TruLab Cystatin C Level 1

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

DIASYS TruCal Cystatin C

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

DIASYS TruCal Albumin U/CSF

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2022

DiaSys TruCal Protein

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2022

SIEMENS Protein S Ac

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2022

SIEMENS LA1 Screening Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2022

DIASYS TruCal CRP

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

DIASYS TruLab Albumin U/ CSF Level 1

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2022

REVOHEM ADP

Manufacturer:

HYPHEN BIOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2022

REVOHEM™ Arachidonic Acid

Manufacturer:

HYPHEN BIOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

SIEMENS Coagulation Factor II Deficient Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

INNOVANCE Free PS Ag

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2022

SIEMENS Coagulation Factor X Deficient Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2022

SIEMENS vWF Ag

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

REVOHEM Epinephrine

Manufacturer:

HYPHEN BIOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

REVOHEM Ristocetin

Manufacturer:

HYPHEN BIOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

SIEMENS Thromboclotin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2022

BERICHROM Plasminogen

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 24, 2022

PROC Global

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

SIEMENS LA2 Confirmation Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

SYSMEX Semi-Automated Blood Coagulation Analyzer CA-104 and Accessories

Manufacturer:

LABITEC - LABOR BIOMEDICAL TECHNOLOGIES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2022

SIEMENS LA Control Low

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

SIEMENS LA Control High

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

SIEMENS Control Plasma N

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

CYFLOW™ Counter

Manufacturer:

SYSMEX PARTEC GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

BIOMAJESTY Lactate FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2022

SYSMEX Automated Hematology Slide Preparation Unit SP-50 and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2022

INNOVANCE D-Dimer Controls

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 2, 2022

MULTIFIBRE U

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2022

SIEMENS Protein C Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2022

SIEMENS Fibrinogen Calibrator Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2022

SIEMENS Imidazole Buffer Solution

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2022

DADE INNOVIN

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 25, 2022

SIEMENS Kaolin Suspension

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 25, 2022

SIEMENS Innovance D-Dimer Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 25, 2022

DADE Owren's Veronal Buffer

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 23, 2022

SIEMENS HEALTHINEERS Coagulation Factor VIII Deficient Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

SIEMENS HEALTHINEERS Coagulation Factor IX Deficient Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

PATHROMTIN SL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 19, 2022

SIEMENS Control Plasma P

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2022

DADE CI-TROL 2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2022

SIEMENS HEALTHINEERS Standard Human Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2022

SIEMENS Calcium Chloride Solution

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

SYSMEX Count Check Beads green

Manufacturer:

SYSMEX PARTEC GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2022

DIASYS LDL-c Direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

SYSMEX BX-Series HDL-c Direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

BIOMAJESTY B-Hydroxybutyrate 21 FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

BIOMAJESTY HDL-c Direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

BIOMAJESTY LDH 21 FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

BIOMAJESTY LDL-c Direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

SYSMEX Sheath Fluid

Manufacturer:

SYSMEX EUROPE SE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 14, 2022

SIEMENS Factor VIII Chromogenic Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2022

SYSMEX Decontamination Solution

Manufacturer:

SYSMEX PARTEC GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 14, 2022

SYSMEX Hypochlorite Solution

Manufacturer:

SYSMEX PARTEC GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 10, 2022

SIEMENS Coagulation Factor V Deficient Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 8, 2022

SYSMEX Cleaning Solution

Manufacturer:

SYSMEX PARTEC GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 7, 2022

PROC Control Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2022

SIEMENS Coagulation Factor VII Deficient Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2022

INNOVANCE VWF Ac

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2022

SIEMENS Coagulation Factor XII Deficient Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2022

SIEMENS BC Von Willebrand Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2022

SIEMENS Coagulation Factor XI Deficient Plasma

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2022

DADE CI-TROL 3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2022

SIEMENS PT-Multi Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2022

DADE Ci-Trol 1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2022

WRP Check EX

Manufacturer:

DASH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2022

SYSMEX BX-4000 Clinical Chemistry Analyzer without ISE and Accessories

Manufacturer:

FURUNO ELECTRIC, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2022

DIASYS Ethanol Standard FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2022

SYSMEX BX Series UIBC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2022

SYSMEX BX-Series Pancreatic amylase CC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2022

SYSMEX BX-3010 Clinical Chemistry Analyzer and Accessories

Manufacturer:

FURUNO ELECTRIC CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2022

DIASYS Ethanol FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 23, 2022

BIOMAJESTY Cholesterol FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS, GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2022

SYSMEX BX-Series LDH FS IFCC

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2022

SYSMEX BX-Series CK-NAC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2022

BIOMAJESTY Phospholipids FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2022

SYSMEX BX- Series Bicarbonate FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2022

DiaSys TruLab Ethanol

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

DiaSys TruCal Apo A1/B

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

BIOMAJESTY Prealbumin FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 11, 2022

DiaSys TruLab L Level 1

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2022

DIASYS TruLab Lp(a) Level 1

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2022

DIASYS TruLab Lp(a) Level 2

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2022

DIASYS TruCal Lp(a) 21

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2022

SYSMEX BX-Series Phosphate FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

DiaSys TruLab P

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

WRP CHECK™

Manufacturer:

DASH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2022

DiaSys TruCal CK-MB

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2022

SYSMEX BX-Series Magnesium XL FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2022

DiaSys TruCal Lipid

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 19, 2022

DiaSys TruLab N

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2022

DiaSys TruCal U

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2022

SYSMEX Semi-Automated Urine Chemistry Analyzer UC-1000 and Accessories

Manufacturer:

KOMATSU ELECTRONICS, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2022

SYSMEX BX-Series Lipase DC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2022

SYSMEX BX-Series Total Protein FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2022

SYSMEX BX-Series Uric Acid FS Toos

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2022

MEDITAPE UC-12S

Manufacturer:

EIKEN CHEMICAL, CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2022

MEDITAPE UC-10S

Manufacturer:

EIKEN CHEMICAL, CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 27, 2022

BIOMAJESTY Uric Acid FS Toos

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2021

BIOMAJESTY Triglycerides FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2021

SYSMEX BX-Series HDL-C Immuno FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 25, 2021

SYSMEX BX Series Glucose Hexokinase FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 25, 2021

Count Check Beads green

Manufacturer:

SYSMEX PARTEC GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2021

SYSMEX BX-Series LDL-C Select FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2021

BIOMAJESTY Alpha-Amylase CC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

BIOMAJESTY Pancreatic Amylase CC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS, GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

BIOMAJESTY ASAT (GOT) FS (IFCC mod.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

BIOMAJESTY Total Protein FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEM GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2021

SYSMEX BX-Series Gamma GT FS (Szasz mod./IFCC stand.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2021

BIOMAJESTY LDL-C Select FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS, GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2021

SYSMEX BX-Series CK-MB FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2021

BIOMAJESTY Lipase DC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2021

BIOMAJESTY Immunoglobulin M FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2021

SYSMEX BX-Series α-Amylase CC FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2021

SYSMEX Cleaning Solution

Manufacturer:

SYSMEX PARTEC GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 10, 2021

BIOMAJESTY Ferritin FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2021

BIOMAJESTY Phosphate FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2021

BIOMAJESTY Creatinine PAP FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2021

SYSMEX BX-Series Urea FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2021

SYSMEX Decontamination Solution

Manufacturer:

SYSMEX PARTEC GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 7, 2021

BIOMAJESTY Gamma-GT FS (Szasz mod./ IFCC stand)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2021

BIOMAJESTY CRP FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2021

BIOMAJESTY Creatinine FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2021

BIOMAJESTY Glucose Hexokinase FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2021

BIOMAJESTY Calcium P FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2021

BIOMAJESTY Bilirubin Auto Total FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2021

BIOMAJESTY Bilirubin Auto Direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2021

BIOMAJESTY ALAT (GPT) FS (IFCC mod.)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2021

SYSMEX BX-Series CRP FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2021

SYSMEX BX-Series Bilirubin Auto Total FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

SYSMEX BX-Series Bilirubin Auto Direct FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

SYSMEX BX-Series Alkaline phosphatase FS IFCC 37 °C

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

SYSMEX BX-Series Creatinine FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

SYSMEX BX- Series Creatinine PAP FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

SYSMEX BX-SERIES Calcium P FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

DIASYS Albumin FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2021

SYSMEX BX-Series Triglycerides FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2021

SYSMEX BX-SERIES Cholesterol FS 10'

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2021

BIOMAJESTY Alkaline Phosphatase FS IFCC mod 37°C

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2021

BIOMAJESTY Albumin in Urine/ CSF FS (Microalbumin)

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2021

RAmini RACK HANDLER

Manufacturer:

JEOL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2021

BIOMAJESTY Apolipoprotein B FS

Manufacturer:

DIASYS DIAGNOSTIC SYSTEMS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2021

GENEDRIVE HCV ID Kit

Manufacturer:

GENEDRIVE DIAGNOSTICS LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 16, 2021

XN CHECK™ L1

Manufacturer:

DASH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2021

EIGHTCHECK - 3WP-N

Manufacturer:

DASH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2021

SYSMEX KX-21 Automated Hematology Analyzer and Accessories

Manufacturer:

SYSMEX CORPORATION KAKOGAWA FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2021

BioMajesty Reagent Probe Wash 1

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 18, 2021

BIOMAJESTY Cuvette Conditioner EX

Manufacturer:

JEOL YAMAGATA CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 18, 2021

BioMajesty Reagent Probe Wash S

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 14, 2021

SYSMEX XS-500i Automated Hematology Analyzer and Accesories

Manufacturer:

SYSMEX CORPORATION KAKOGAWA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2021

BIOMAJESTY Cuvette Wash Solution 7

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 10, 2021

SYSMEX Fully Automated Urine Particle Analyzer UF-500i and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 9, 2021

UX II PACK-SED

Manufacturer:

SYSMEX INTERNATIONAL REAGENTS, CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2021

HISCL™ Anti-HBc Assay Kit

Manufacturer:

JAPAN LYOPHILIZATION LABORATORY.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 27, 2021

HISCL Anti-HBe Calibrator

Manufacturer:

JAPAN LYOPHILIZATION LABORATORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 23, 2021

MEDITAPE CHECK 1

Manufacturer:

SYSMEX INTERNATIONAL REAGENTS CO., LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

HISCL Anti-HBc Calibrator

Manufacturer:

JAPAN LYOPHILIZATION LABORATORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2021

XN CAL

Manufacturer:

DASH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2021

UF II Pack ™ - Thirst

Manufacturer:

SYSMEX INTERNATIONAL REAGENTS, CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2021

SYSMEX XP-300 Automated Hematology Analyzer and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2021

SYSMEX SCS™ -1000

Manufacturer:

DASH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2021

SYSMEX XN CHECK BF

Manufacturer:

DASH.INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2021

SYSMEX KX-21N Automated Hematology Analyzer and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2021

UF II Pack - Bac

Manufacturer:

SYSMEX INTERNATIONAL REAGENTS, CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2021

SYSMEX POCH-100i Automated Hematology Analyzer and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2021

HISCL Anti-HCV Calibrator

Manufacturer:

SYSMEX INTERNATIONAL REAGENTS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2021

XN CAL™ PF

Manufacturer:

DASH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2021

HISCL™ Anti-HBs Calibrator

Manufacturer:

JAPAN LYOPHILIZATION LABORATORY.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 1, 2021

SYSMEX UF-5000 Fully Automated Urine Particle Analyzer and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2021

HISCL Anti-TP Assay Kit

Manufacturer:

JAPAN LYOPHILIZATION LABORATORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2021

HISCL PSA Assay Kit

Manufacturer:

PRICES LABORATORIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 20, 2021

HISCL™ AFP Calibrator

Manufacturer:

PRICES LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

HISCL™ Anti-HBs Assay Kit

Manufacturer:

JAPAN LYOPHILIZATION LABORATORY.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 17, 2021

HISCL™ AFP Assay Kit

Manufacturer:

PRICES LABORATORIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

HISCL CEA Calibrator

Manufacturer:

PRICES LABORATORIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2021

HISCL PSA Calibrator

Manufacturer:

PRICES LABORATORIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2021

BIOMAJESTY Immunoglobulin G FS

Manufacturer:

DIASYS DIAGNOSTICS SYSTEMS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2021

SYSMEX Automated Blood Coagulation Analyzer CS-5100 and Accessories

Manufacturer:

SYSMEX CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 16, 2021

SYSMEX CA-660 Fully Automated Coagulation Analyzer and Accessories

Manufacturer:

SYSMEX RA.CO.LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2021

BIOMAJESTY Reagent Probe Wash 2

Manufacturer:

JEOL YAMAGATA CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 12, 2021

UF II Sheath

Manufacturer:

SYSMEX INTERNATIONAL REAGENTS,CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2021

Genedrive (HCV)

Manufacturer:

GENEDRIVE DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 6, 2020

UX II PACK™-BAC

Manufacturer:

SYSMEX ASIA PACIFIC PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025