EUDAMED registration 06974501891709NoMonoclonal Mouse Anti-Human CD79a/PE, Clone HM47
- Risk class
- IVD General
- CND nomenclatures code
- W0103080299
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06974501891709
- Basic UDI
- B-06974501891709
- Version date
- July 22, 2022
- Manufacturer last update
- September 14, 2021
- Active status
- No
- Manufacturer name
- Agilent Biosciences (Hangzhou) Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- No. 208 Zhenzhong Road Hangzhou
- tom.chen@agilent.com
- Name
- Wellkang Ltd
- SRN
- XI-AR-000001836
- Country
- United Kingdom (Northern Ireland only)
- Address
- Enterprise Hub, NW Business Complex, Derry
- AuthRep@CE-marking.eu
- Telephone
- +44(33)33031126
- Competent authority
- The Medicines and Healthcare Products Regulatory Agency
- Applicable legislation
- IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
- Placed on the market
- Denmark
- Human tissues
- No
- Animal tissues
- No
MONOCLONAL ANTIBODIES FOR CYTOPLASMATIC ANTIGENS - OTHER
Access comprehensive regulatory information for Monoclonal Mouse Anti-Human CD79a/PE, Clone HM47 in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 06974501891709 and manufactured by Agilent Biosciences (Hangzhou) Co., Ltd. in China.
This page provides complete registration details including manufacturer information, authorized representative details, competent authority (The Medicines and Healthcare Products Regulatory Agency), 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.