MINDRAY SARS-COV-2 IgG(CLIA) Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) - Indonesia BPOM Medical Device Registration

MINDRAY SARS-COV-2 IgG(CLIA) Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303024068. The device is manufactured by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MINDRAY MEDICAL 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

BPOM Registered

Risk Class Kelas Resiko : B

MINDRAY SARS-COV-2 IgG(CLIA) Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA)

Analysis ID: AKL 20303024068

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Country of Origin

China

Authorized Representative

PT. MINDRAY MEDICAL INDONESIA

AR Address

Menara DEA II Lt.17, Jl. Mega Kuningan Barat Kav.E4.3 No.1-2, Kel. Kuningan Timur, Kec.Setiabudi Kawasan Mega Kuningan, Jakarta Selatan

Registration Date

Dec 30, 2020

Expiry Date

Jun 29, 2025

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Products from the same manufacturer (10 products)

MINDRAY SARS-COV-2 IgG(CLIA) Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) - Indonesia BPOM Medical Device Registration

Risk Classification

Product Class

Manufacturer

Country of Origin

Authorized Representative

AR Address

Registration Date

Expiry Date

Product Type

DJ Fang

MINDRAY ME7 Diagnostic Ultrasound System

MINDRAY ASO/CRP/RF Triple Control

MINDRAY ALD Calibrators

MINDRAY Hypertension Multi Control (H)

MINDRAY M-5LEO (I) Bright

MINDRAY LC LYSE

MINDRAY Urine Sediment Control Level III

MINDRAY Hypertension Multi Control (L)

MINDRAY ACTH Control (L)

MINDRAY ALD II Aldosterone (CLIA)