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TESTLINE BLOT-LINE ANA - Indonesia BPOM Medical Device Registration

TESTLINE BLOT-LINE ANA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305320869. The device is manufactured by TESTLINE CLINICAL DIAGNOSTIC, SPOL. S.R.O from Czech Republic, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FLEXYLABS INSTRUMENT 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
TESTLINE BLOT-LINE ANA
Analysis ID: AKL 20305320869

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Czech Republic

Authorized Representative

PT. FLEXYLABS INSTRUMENT INDONESIA

AR Address

Ruko Poris Garden Blok A9A No.1A

Registration Date

May 25, 2023

Expiry Date

Jan 01, 2027

Product Type

Immunological Test System

Antinuclear antibody immunological test system.

Invitro Diagnostics

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