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Single Patient Use Powered Endo Cutter
EUDAMEDClass IIa (EU MDR)
Ref Certificate No. G15 004954 0006 Rev. 00Model IEC-60、IEC-160、IEC-260
Identity
- Trade Name
- Single Patient Use Powered Endo Cutter EUDAMED
- Device Name
- Single Patient Use Powered Endo Cutter EUDAMED
- Model / Reference
- IEC-60、IEC-160、IEC-260 EUDAMEDCertificate No. G15 004954 0006 Rev. 00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946912209138 EUDAMED06946912209114 EUDAMED
- Basic UDI-DI
- 694691220049J9 EUDAMED
- Direct Marketing DI
- 06946912209138 EUDAMED06946912209114 EUDAMED
- EMDN Code
- H020301040201,H020301040202,H020301040299 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Single Patient Use Powered Endo Cutter by Golden Stapler Surgical Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 694691220049J9 | Class IIa | 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 (2)
- EUDAMED ed65a2ba-893b-4398-9116-8a285210b511 61 fields · synced Jul 22, 2026
- EUDAMED f0bfa410-2bd8-44cb-8c68-22585826a5c5 61 fields · synced May 19, 2026