EUDAMED registration 06928103081204NoReal-time PCR Detection System
- Risk class
- Class A
- CND nomenclatures code
- W02050116
- Trade name
- Real-time PCR Detection System
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06928103081204
- Basic UDI
- 69281030812XFW
- Version date
- August 31, 2023
- Manufacturer last update
- July 07, 2022
- Active status
- No
- Manufacturer name
- Daan Gene Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- No. 19 Xiangshan Road, Science Park, High & New Technology Development District Guangzhou
- hj@daangene.com
- Name
- Lotus NL B.V.
- SRN
- NL-AR-000000121
- Country
- Netherlands
- Address
- Koningin Julianaplein 10, 1e Verd The Hague
- peter@lotusnl.com
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
- Placed on the market
- Netherlands
- Human tissues
- No
- Animal tissues
- No
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
Access comprehensive regulatory information for Real-time PCR Detection System in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06928103081204 and manufactured by Daan Gene Co., Ltd. in China.
This page provides complete registration details including trade name (Real-time PCR Detection System), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.