Disposable Endoscopic Staplers and Reload Unit
- Risk class
- Class IIb
- CND nomenclatures code
- H02030106
- Trade name
- BEIEN-SURG
- Implantable
- Yes
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06971767873487
- Basic UDI
- B-06971767873487
- Version date
- April 27, 2022
- Manufacturer last update
- December 03, 2021
- Active status
- No
- Manufacturer name
- Wuxi Beien Surgery Device Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- No.99 Furong San Road Wuxi
- Service@Beien-Surgery.com
- Name
- Prolinx GmbH
- SRN
- DE-AR-000005129
- Country
- Germany
- Address
- 56 Brehmstr Düsseldorf
- med@eulinx.eu
- Telephone
- +4921131054698
- Competent authority
- DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- United Kingdom (Northern Ireland only)
- Market available
- United Kingdom (Northern Ireland only):2020-01-03~2024-05-26
- Human tissues
- No
- Animal tissues
- No
LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY
Access comprehensive regulatory information for Disposable Endoscopic Staplers and Reload Unit in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 06971767873487 and manufactured by Wuxi Beien Surgery Device Co., Ltd. in China.
This page provides complete registration details including trade name (BEIEN-SURG), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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.