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PRIMELINE Urea, Urease/GLDH - Indonesia BPOM Medical Device Registration

PRIMELINE Urea, Urease/GLDH is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221242. The device is manufactured by BEIJING STRONG BIOTECHNOLOGIES, INC from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MULTI SARANA MEDIKA.

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.

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BPOM Registered
Risk Class Kelas Resiko : B
PRIMELINE Urea, Urease/GLDH
Analysis ID: AKL 20101221242

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MULTI SARANA MEDIKA

AR Address

Komp. Gading Bukit Indah Jl. Bukit Gading Raya Blok B Kav. No.1

Registration Date

Aug 12, 2022

Expiry Date

Aug 11, 2025

Product Type

Clinical Chemistry Test System

Urea nitrogen test system (kit & cair)

Invitro Diagnostics

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