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AFIAS TOTAL β-hCG - Indonesia BPOM Medical Device Registration

AFIAS TOTAL β-hCG is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101420386. The device is manufactured by BODITECH MED INC., from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BODITECH MED INDONESIA.

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
AFIAS TOTAL β-hCG
Analysis ID: AKL 20101420386

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BODITECH MED INC.,

Country of Origin

Korea

Authorized Representative

PT. BODITECH MED INDONESIA

AR Address

Ruko Alam Sutera, Jalur Sutera Kavling 25 B-C No.1

Registration Date

Mar 10, 2024

Expiry Date

Oct 25, 2028

Product Type

Clinical Chemistry Test System

Human chorionic gonadotropin (HCG) test system (card)

Invitro Diagnostics

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