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FTD SARS-CoV-2 - Indonesia BPOM Medical Device Registration

FTD SARS-CoV-2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303025283. The device is manufactured by FAST TRACK DIAGNOSTICS LUXEMBOURG S.ร .R.L. from Luxembourg, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS 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
FTD SARS-CoV-2
Analysis ID: AKL 20303025283

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Luxembourg

Authorized Representative

PT. SIEMENS HEALTHINEERS INDONESIA

AR Address

Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl. Tahi Bonar Simatupang Kav. 88, Kel. Kebagusan, Kec. Pasar Minggu, Jakarta Selatan, DKI Jakarta

Registration Date

Sep 12, 2022

Expiry Date

Aug 11, 2024

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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