ZECEN POClia Thyroid-stimulating Hormone (TSH) - Indonesia BPOM Medical Device Registration
ZECEN POClia Thyroid-stimulating Hormone (TSH) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101322867. The device is manufactured by TAIZHOU ZECEN BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INDARUM ASTAGUNA.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
TAIZHOU ZECEN BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
PT. INDARUM ASTAGUNAAR Address
Ruko Permata Boulevard Blok AQ, Jl. Pos Pengumben Raya No. 1, Jakarta โ 11630 Telp. : (021) 5872778, Fax. (021) 5872779
Registration Date
Mar 31, 2023
Expiry Date
May 05, 2027
Product Type
Clinical Chemistry Test System
Thyroid stimulating hormone test system (kit & cair)
Invitro Diagnostics
MACCURA Coagulation Quality Control Plasma (CQC) Level 2
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Coagulation Quality Control Plasma (CQC) Level 1
MACCURA BIOTECHNOLOGY CO., LTD.
ZECEN POCLia Free thyroxine (FT4)
TAIZHOU ZECEN BIOTECH CO., LTD.
ZECEN POClia 8 Automatic Chemiluminescence Immunoassay Analyzer
TAIZHOU ZECEN BIOTECH CO., LTD.
MACCURA Coagulation Quality Control Plasma (CQC) Level 1
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Coagulation Analyzer Wash Buffer A (Coa-Wash A)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Coagulation Analyzer Wash Buffer B (Coa-Wash B)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Automatic Coagulation Analyzer
MACCURA MEDICAL INSTRUMENT CO., LTD.
MACCURA Fibrinogen (FIB)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA APTT
MACCURA BIOTECHNOLOGY CO., LTD.

