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Powered Endoscopic Stapler
EUDAMEDClass IIb (EU MDR)
Ref OEL45-460Ref OEL60-460Ref OEC45-360Ref OES60-260
Identity
- Trade Name
- Powered Endoscopic Stapler EUDAMED
- Device Name
- Powered Endoscopic Staplers EUDAMED
- Model / Reference
- OEL45-460 EUDAMEDOEL60-460 EUDAMEDOEC45-360 EUDAMEDOES60-260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972304750879 EUDAMED16972304750909 EUDAMED16972304750862 EUDAMED16972304750886 EUDAMED
- Basic UDI-DI
- 697230475000875 EUDAMED
- EMDN Code
- H020301040101,H020301040102 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMEDFrance 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 (4)
- EUDAMED d2bd66a6-e59d-4115-9e55-979afc0b98bc 61 fields · synced Jul 20, 2026
- EUDAMED 8ee7048d-04c1-465c-b4ff-fb851941c8f9 61 fields · synced May 17, 2026
- EUDAMED 8963a6e8-9ae2-4ac9-a8d3-94e1a2d009c9 61 fields · synced May 17, 2026
- EUDAMED 4f0e4a52-8a1b-4ba4-b5b4-741c4d78e0c9 61 fields · synced May 19, 2026