ZECEN POCLia Free thyroxine (FT4) - Indonesia BPOM Medical Device Registration

ZECEN POCLia Free thyroxine (FT4) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101322833. 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.

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BPOM Registered

Risk Class Kelas Resiko : B

ZECEN POCLia Free thyroxine (FT4)

Analysis ID: AKL 20101322833

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

TAIZHOU ZECEN BIOTECH CO., LTD.

Country of Origin

China

Authorized Representative

PT. INDARUM ASTAGUNA

AR Address

Ruko Permata Boulevard Blok AQ, Jl. Pos Pengumben Raya No. 1, Jakarta – 11630 Telp. : (021) 5872778, Fax. (021) 5872779

Registration Date

Mar 26, 2023

Expiry Date

May 05, 2027

Product Type

Clinical Chemistry Test System

Free thyroxine test system (kit & cair)

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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