Daan Gene Co., Ltd. - Manufacturer Profile

Explore comprehensive manufacturer profile for Daan Gene Co., Ltd. through Pure Global AI's free EU medical device database. This company manufactures 194 medical devices registered with EUDAMED across 4 risk classes based in China.

This page provides detailed insights including recent registrations, risk class distribution (IVD Annex II List B: 3, Class A: 89, IVD General: 100, IVD Annex II List A: 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.

Free Manufacturer Profile

194 Devices

4 Risk Classes

Daan Gene Co., Ltd.

Manufacturer - China

194

Total Devices

Risk Classes

2022

Earliest Version

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Recent Products (Latest 10)

Most recently updated devices in the database

Device Name	Risk Class	Detail
Nucleic Acid Extraction Instrument	Class A
Fluorimetric Immunoassay Analyser	Class A
RNA/DNA Extraction or Purification Kit	Class A
RNA/DNA Extraction or Purification Kit	Class A
Real-time PCR Detection System	Class A
RNA/DNA Extraction or Purification Kit	Class A
RNA/DNA Extraction or Purification Kit	Class A
RNA/DNA Extraction or Purification Kit	Class A
Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)	IVD Annex II List B
Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)	IVD Annex II List B

Risk Class Distribution

Breakdown by risk classification

IVD General

100(51.5%)

Class A

89(45.9%)

IVD Annex II List B

3(1.5%)

IVD Annex II List A

2(1.0%)

Top Authorized Representatives

Most common authorized representatives for this manufacturer

Authorized Representative	Device Count	Percentage
Lotus NL B.V.	119	61.3%
Medical Device Safety Service GmbH (MDSS)	72	37.1%
MDSS GmbH	3	1.5%