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SHANGHAI ZJ BIO-TECH CO., LTD - Manufacturer Profile

Explore comprehensive manufacturer profile for SHANGHAI ZJ BIO-TECH CO., LTD through Pure Global AI's free EU medical device database. This company manufactures 312 medical devices registered with EUDAMED across 3 risk classes based in China.

This page provides detailed insights including recent registrations, risk class distribution (IVD General: 272, Class A: 38, IVD Annex II List B: 2), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.

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312 Devices
3 Risk Classes
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer - China
312
Total Devices
3
Risk Classes
2022
Earliest Version
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Recent Products (Latest 10)
Most recently updated devices in the database
Device NameRisk ClassDetail
8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit
IVD General
10 Viral Diarrhea Pathogens Multiplex Real Time PCR Kit
IVD General
Enterotoxigenic E. Coli (ETEC) Real Time PCR Kit
IVD General
Cryptococcus Neoformans Real Time PCR Kit
IVD General
Respiratory Syncytial Virus (RSV) Typing A &B Real Time RT-PCR Kit
IVD General
Coxiella Burnetii Rickettsia prowazekii Rickettsia typhi Multiplex Real Time PCR Kit
IVD General
Clostridium Difficile Real Time PCR Kit
IVD General
Plasmodium Ovale Real Time PCR Kit
IVD General
Rift Valley Fever Virus (RVFV) Real Time RT-PCR Kit
IVD General
6 RP Panel I
IVD General
Risk Class Distribution
Breakdown by risk classification
IVD General
272(87.2%)
Class A
38(12.2%)
IVD Annex II List B
2(0.6%)
Top Authorized Representatives
Most common authorized representatives for this manufacturer
Authorized RepresentativeDevice CountPercentageView
RIOMAVIX SOCIEDAD LIMITADA
26384.3%
Lotus NL B.V.
4915.7%