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SuperFlex cTnI Control - Indonesia BPOM Medical Device Registration

SuperFlex cTnI Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421801. The device is manufactured by SUZHOU SYM-BIO LIFESCIENCE CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is DARMA LABORA 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
SuperFlex cTnI Control
Analysis ID: AKL 20101421801

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

DARMA LABORA INDONESIA

AR Address

KAWASAN INDUSTRI JABABEKA 7, BLOK B3/B, DESA WANGUNHARJA

Registration Date

Sep 12, 2024

Expiry Date

Apr 24, 2029

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

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