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AFIAS Tn-I Plus - Indonesia BPOM Medical Device Registration

AFIAS Tn-I Plus is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101420122. 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. 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 Tn-I Plus
Analysis ID: AKL 20101420122

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BODITECH WITH 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

Feb 10, 2025

Expiry Date

Oct 25, 2028

Product Type

Clinical Chemistry Test System

Creatine phosphokinase/creatine kinase or isoenzymes test system(kit & cair)

Invitro Diagnostics

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