Equipment Covers
- Risk class
- Class I
- CND nomenclatures code
- T030199
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06959221713593
- Basic UDI
- 69592217A001MM
- Version date
- March 10, 2025
- Manufacturer last update
- March 21, 2023
- Active status
- No
- Manufacturer name
- Premier Guard Zhongshan Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- Huanmao Yiroad. No.52 Torch Development Zone Zhongshan City, Guangdong
- Arao@premierguard.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
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Netherlands
- Human tissues
- No
- Animal tissues
- No
COVERS, INSTRUMENTS AND EQUIPMENT - OTHER
Access comprehensive regulatory information for Equipment Covers in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06959221713593 and manufactured by Premier Guard Zhongshan 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.