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Disposable Linear Cutter Staplers and Reloads
EUDAMEDClass IIb (EU MDR)
Ref DCR B-60B
Identity
- Trade Name
- Disposable Linear Cutter Staplers and Reloads EUDAMED
- Device Name
- Disposable Linear Cutter Staplers and Reloads EUDAMED
- Model / Reference
- DCR B-60B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946480568637 EUDAMED
- Basic UDI-DI
- B-06946480568637 EUDAMED
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Linear Cutter Staplers and Reloads by Sinolinks Medical Innovation, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06946480568637 | 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 558d1f4a-3ee4-41b8-937e-334b90484441 61 fields · synced May 23, 2026