PROLINE - b CRP FS - Indonesia BPOM Medical Device Registration

PROLINE - b CRP FS is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305026306. The device is manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PRODIA DIAGNOSTIC LINE.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

BPOM Registered

Risk Class Kelas Resiko : B

PROLINE - b CRP FS

Analysis ID: AKL 20305026306

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

DIASYS DIAGNOSTIC SYSTEMS GMBH.

Country of Origin

Germany

Authorized Representative

PT. PRODIA DIAGNOSTIC LINE

AR Address

Kawasan Industri Jababeka III Jl. Tekno 1 Blok C 2 D - E - F, Kel. Pasirgombong, Kec. Cikarang Utara, Kab. Bekasi, Jawa Barat Telp. 021-89872722

Registration Date

Feb 06, 2022

Expiry Date

Feb 05, 2025

Product Type

Immunological Test System

C-reactive protein immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from DIASYS DIAGNOSTIC SYSTEMS GMBH.

Products from the same manufacturer (10 products)

PROLINE - b CRP FS - Indonesia BPOM Medical Device Registration

Risk Classification

Product Class

Manufacturer

Country of Origin

Authorized Representative

AR Address

Registration Date

Expiry Date

Product Type

DJ Fang

DIALINE BioCal HDL/LDL

DIALINE Alkaline Washing Solution

DIALINE Bionorm Universal Control Serum

DIALINE BioCAL Universal Calibrator

DIALINE Lipase Direct Colorimetric

DIALINE CK-MB IFCC/DGKC

DIALINE CK-NAC IFCC/DGKC

YUMIZEN C Urine Level 2 Control

DIALINE Cholesterol CHOD-PAP

DIALINE ALAT/ALT (GPT)

PROLINE - a Albumin in Urine/CSF FS (Microalbumin)

PROLINE – b Iron FS Ferene

PROLINE – b Phosphate FS

PROLINE – b HDL-c direct FS

PROLINE – b LDL-c direct FS

PROLINE – a CRP U-hs

PROLINE - b TruLab Cystatin C level 2

PROLINE - b TruLab Cystatin C level 1

PROLINE – b TruLab CRP Level 2

PROLINE – b TruCal CRP U