Manufacturer profile

DENKA CO., LTD.

IndonesiaJapan20 products registered

VerifiedKemenkes (Ministry of Health) · official registry

Total Products

Product Names

Product Classes

Risk Classes

Regulatory footprint

Search DENKA CO., LTD. across other regulatory registries

Risk classification breakdown

Distribution of products across risk classes

Kelas Resiko : B1155.0% of total

Kelas Resiko : C840.0% of total

Kelas Resiko : D15.0% of total

Product class portfolio

Products organized by product class

Kelas : 2

ARCHITECT PIVKA-II Controls, ARCHITECT PIVKA-II Calibrators, ARCHITECT PIVKA-II Reagent Kit, ALINITY i PIVKA-II Calibrators, ALINITY i PIVKA-II Reagent Kit ... and 14 more products in this class

19 Products

Kelas : 3

ARCHITECT HCV Ag Reagent Kit

1 Products

Recent registrations (20 most recent)

Most recently registered products with Ministry of Health

ARCHITECT HCV Ag Reagent Kit

Nov 26, 2024

Class: Kelas : 3
Risk Class: Kelas Resiko : D

ARCHITECT PIVKA-II Controls

Nov 22, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : C

ARCHITECT PIVKA-II Calibrators

Nov 22, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : C

ARCHITECT PIVKA-II Reagent Kit

Nov 22, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : C

ALINITY i PIVKA-II Calibrators

Nov 14, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : C

ALINITY i PIVKA-II Reagent Kit

Nov 14, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : C

ALINITY i PIVKA-II Controls

Nov 14, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : C

BECKMAN COULTER Myoglobin

Jul 3, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ALINITY i SCC Reagent Kit

Jun 4, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ALINITY i SCC Controls

Jun 4, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ARCHITECT SCC Reagent Kit

May 30, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ARCHITECT SCC Controls

May 29, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ARCHITECT SCC Calibrators

May 20, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ALINITY i SCC Calibrators

May 14, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ARCHITECT Insulin Calibrators

Apr 20, 2023

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ARCHITECT Insulin Reagent Kit

Apr 10, 2023

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ARCHITECT Insulin Controls

Apr 6, 2023

Class: Kelas : 2
Risk Class: Kelas Resiko : B

BECKMAN COULTER Myoglobin Calibrator

Feb 9, 2023

Class: Kelas : 2
Risk Class: Kelas Resiko : B

ARCHITECT ProGRP Calibrators

Sep 21, 2022

Class: Kelas : 2
Risk Class: Kelas Resiko : C

ARCHITECT ProGRP Reagent Kit

Sep 21, 2022

Class: Kelas : 2
Risk Class: Kelas Resiko : C

About this profile

DENKA CO., LTD. from Japan is a medical device manufacturer with 20 registered products in the Indonesia Ministry of Health database through Pure Global AI's free platform. The company produces 20 unique product types across 2 product classes.

This page provides comprehensive manufacturer intelligence including complete product portfolio, risk class distribution, and product class analysis. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify manufacturers, analyze portfolios, and discover partnership opportunities efficiently.