Pure Global

BIOTEPHY SARS-CoV-2 Real-time rtPCR Detection Kit (Lyophilized) - Indonesia BPOM Medical Device Registration

BIOTEPHY SARS-CoV-2 Real-time rtPCR Detection Kit (Lyophilized) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303123925. The device is manufactured by QINGDAO BIOTEPHY CO. LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is HAS PUTRA 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
BIOTEPHY SARS-CoV-2 Real-time rtPCR Detection Kit (Lyophilized)
Analysis ID: AKL 20303123925

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

HAS PUTRA INDONESIA

AR Address

JL.PAL PUTIH NO.72

Registration Date

Feb 01, 2024

Expiry Date

Feb 01, 2026

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing