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APTIMA SARS-COV-2 Assay Controls Kit - Indonesia BPOM Medical Device Registration

APTIMA SARS-COV-2 Assay Controls Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303027424. The device is manufactured by HOLOGIC, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BIOMEDIKAL SCIENTIFIC 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
APTIMA SARS-COV-2 Assay Controls Kit
Analysis ID: AKL 20303027424

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

HOLOGIC, INC.

Country of Origin

United States

Authorized Representative

PT. BIOMEDIKAL SCIENTIFIC INDONESIA

AR Address

18 Office Park 22nd F1 Suite E, F &G, Jalan TB SIMATUPANG 18

Registration Date

Sep 28, 2022

Expiry Date

Sep 30, 2025

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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