EUDAMED registration 00816784020680NoACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100
- Risk class
- IVD Annex II List B
- CND nomenclatures code
- W0105080801
- Trade name
- ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00816784020680
- Basic UDI
- B-00816784020680
- Version date
- July 26, 2023
- Manufacturer last update
- July 24, 2023
- Active status
- No
- Manufacturer name
- LGC Clinical Diagnostics, Inc.
- Country
- United States
- Country type
- NON_EU
- Address
- 37 Birch Street Milford
- alexander.potter@lgcgroup.com
- Name
- MEDIMARK EUROPE
- SRN
- FR-AR-000000182
- Country
- France
- Address
- 11 RUE EMILE ZOLA BP 2332 GRENOBLE cedex 2
- info@medimark-europe.com
- Telephone
- +33 4 76 86 43 22
- Competent authority
- Agence Nationale de Sécurité du Médicament et des Produits de Santé
- Applicable legislation
- IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
- Placed on the market
- Ireland
- Human tissues
- Yes
- Animal tissues
- No
BACTERIOLOGY CONTROLS - INF.IMM.
Access comprehensive regulatory information for ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 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 00816784020680 and manufactured by LGC Clinical Diagnostics, Inc. in United States.
This page provides complete registration details including trade name (ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sécurité du Médicament et des Produits de Santé), 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.