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HOTGEN Thyroxine test (Chemiluminescence Immunoassay) - Indonesia BPOM Medical Device Registration

HOTGEN Thyroxine test (Chemiluminescence Immunoassay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421325. The device is manufactured by BEIJING HOTGEN BIOTECH CO.ID from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ZEFINDO DARYA MEGATAMA.

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
HOTGEN Thyroxine test (Chemiluminescence Immunoassay)
Analysis ID: AKL 20101421325

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

ZEFINDO DARYA MEGATAMA

AR Address

Jl. Jemursari No 329-331 B, Kode Pos 60239, Desa/Kelurahan Sidosermo, Kec. Wonocolo, Kota Surabaya, Prov. Jawa Timur

Registration Date

Jul 05, 2024

Expiry Date

Nov 28, 2028

Product Type

Clinical Chemistry Test System

Thyroxine-binding globulin test system (kit & cair)

Invitro Diagnostics

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