Identity
- Trade Name
- Powered Endoscopic Stapler EUDAMED
- Device Name
- Powered Endoscopic Staplers EUDAMED
- Model / Reference
- OEC60-360 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972304750893 EUDAMED
- Basic UDI-DI
- 697230475000875 EUDAMED
- EMDN Code
- H020301040101,H020301040102 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal 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
Powered Endoscopic Stapler by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. — Class IIb — 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 | 697230475000875 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000014087
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d260b5a2-ab45-49e0-98e6-e9747dab9724 61 fields · synced Jun 19, 2026