EUDAMED registration 06928103011409NoDetection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)
- Risk class
- IVD Annex II List B
- CND nomenclatures code
- W0105010117
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06928103011409
- Basic UDI
- B-06928103011409
- Version date
- January 03, 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
- MDSS GmbH
- SRN
- DE-AR-000005430
- Country
- Germany
- Address
- 41 Schiffgraben Hannover
- info@mdssar.com
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
- Placed on the market
- Sweden
- Human tissues
- No
- Animal tissues
- No
CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
Access comprehensive regulatory information for Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing) in the European Union medical device market through Pure Global AI's free database. This IVD Annex II List B device is registered with EU EUDAMED under Primary DI 06928103011409 and manufactured by Daan Gene Co., Ltd. in China.
This page provides complete registration details including 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.