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Optical Q TSH - Indonesia BPOM Medical Device Registration

Optical Q TSH is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101222201. The device is manufactured by OPTIBIO.CO.,LTD from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. KIRANA JAYA LESTARI.

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
Optical Q TSH
Analysis ID: AKL 20101222201

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

OPTIBIO.CO.,LTD

Country of Origin

Korea

Authorized Representative

PT. KIRANA JAYA LESTARI

AR Address

JL. TANAH ABANG II NO. 37

Registration Date

Dec 08, 2022

Expiry Date

Mar 02, 2027

Product Type

Clinical Chemistry Test System

Thyroid stimulating hormone test system (card)

Invitro Diagnostics

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