Disposable Endoscopic Linear Cutter Staplers and Reloads
by Sinolinks Medical Innovation, Inc. China EUDAMED
Ref DER B 60B
EMDN H020301040101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69464805DEC-A/BJ5 | Date30 Mar 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- DER B 60B
- Primary DI / UDI-DI
- 06946480589380
- Basic UDI-DI
- 69464805DEC-A/BJ5
- Direct Marketing DI
- 06946480589380
- EMDN Code
- H020301040101 Single patient straight linear staplers with blade for thoracoscopy
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000010840
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED b7b19721-db0d-4f4e-83b1-75272af54b8f