Pure Global

HUMAN T3 ELISA - Indonesia BPOM Medical Device Registration

HUMAN T3 ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101802639. The device is manufactured by HUMAN Gesellschaft fรผr Biochemica und Diagnostica mbH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SALI POLAPA TOGETHER.

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
HUMAN T3 ELISA
Analysis ID: AKL 20101802639

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

PT. SALI POLAPA TOGETHER

AR Address

Puri Sentra Niaga Blok B 33-34 Jl. Raya Kalimalang 13620

Registration Date

Feb 16, 2023

Expiry Date

Nov 08, 2027

Product Type

Clinical Chemistry Test System

Total triiodothyronine test system (kit & cair)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing