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ICHROMA™ β-HCG - Indonesia BPOM Medical Device Registration

ICHROMA™ β-HCG is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323658. The device is manufactured by BODITECH WITH INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ZOE PELITA NUSANTARA.

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
ICHROMA™ β-HCG
Analysis ID: AKL 20101323658

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BODITECH WITH INC.

Country of Origin

Korea

Authorized Representative

PT. ZOE PELITA NUSANTARA

AR Address

JALAN CIKINI II NO 8 B

Registration Date

Aug 14, 2023

Expiry Date

Oct 01, 2027

Product Type

Clinical Chemistry Test System

Human chorionic gonadotropin (HCG) test system (card)

Invitro Diagnostics

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