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Disposable Endoscopic Linear Cutter Staplers and Reloads
EUDAMEDClass IIb (EU MDR)
Ref DER B 45P
Identity
- Trade Name
- Disposable Endoscopic Linear Cutter Staplers and Reloads EUDAMED
- Device Name
- Disposable endoscopic linear cutter staplers and reloads EUDAMED
- Model / Reference
- DER B 45P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946480589359 EUDAMED
- Basic UDI-DI
- 69464805DEC-A/BJ5 EUDAMED
- Direct Marketing DI
- 06946480589359 EUDAMED
- EMDN Code
- H020301040101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR THORACOSCOPY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Endoscopic Linear Cutter Staplers and Reloads by Sinolinks Medical Innovation, Inc. — Class IIb — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69464805DEC-A/BJ5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sinolinks Medical Innovation, Inc.
- EUDAMED SRN
- CN-MF-000010840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 21e6f5f9-ac3e-4a32-ac85-deb7cb94f6b1 61 fields · synced May 23, 2026