Pure Global

AyoTes Neonatal TSH Kit (TRFIA) - Indonesia BPOM Medical Device Registration

AyoTes Neonatal TSH Kit (TRFIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421370. The device is manufactured by GUANGZHOU FENGHUA BIOTECH CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HEALTHY FAMILY FOCUS.

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
AyoTes Neonatal TSH Kit (TRFIA)
Analysis ID: AKL 20101421370

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. HEALTHY FAMILY FOCUS

AR Address

Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Gambir, Kel. Petojo Selatan

Registration Date

Jul 29, 2024

Expiry Date

Jul 21, 2027

Product Type

Clinical Chemistry Test System

Thyroid stimulating hormone test system (kit & cair)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from GUANGZHOU FENGHUA BIOTECH CO., LTD
Products from the same manufacturer (1 products)