Identity
- Trade Name
- Golden Stapler EUDAMED
- Device Name
- Single Patient Use Linear Cutter and Reload EUDAMED
- Model / Reference
- LCA75Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946912278066 EUDAMED
- Basic UDI-DI
- B-06946912278066 EUDAMED
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Category: Open-surgery manual linear cutting stapler, single-use
Golden Stapler by Golden Stapler Surgical Co., Ltd — Class IIb — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Open-surgery manual linear cutting stapler, single-use.
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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-06946912278066 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Golden Stapler Surgical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014070
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 37e72fe2-9996-4bac-b249-91e105d06d9b 61 fields · synced Oct 6, 2026