Pure Global

Proline LDH 21 FS (IFCC mod.) - Indonesia BPOM Medical Device Registration

Proline LDH 21 FS (IFCC mod.) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101322728. 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 MEDICAL DISTRIBUTION.

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
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
Proline LDH 21 FS (IFCC mod.)
Analysis ID: AKL 20101322728

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

PT. PRODIA MEDICAL DISTRIBUTION

AR Address

Kawasan Industri Jababeka III, Jalan Tekno 1 Blok C 2 D Lantai 1 Lot 1

Registration Date

Mar 06, 2023

Expiry Date

Mar 06, 2026

Product Type

Clinical Chemistry Test System

Lactate dehydrogenase test system (kit & cair)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing