Identity
- Trade Name
- Disposable Safety Scalpels SPA EUDAMED
- Device Name
- Disposable Safety Scalpels EUDAMED
- Model / Reference
- NO.10 EUDAMEDNo.12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36971517662089 EUDAMED
- Basic UDI-DI
- 697151766SafetyScalpel173 EUDAMED
- Direct Marketing DI
- 36971517662089 EUDAMED
- EMDN Code
- V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Disposable Safety Scalpels SPA by Suzhou Kyuan Medical Apparatus 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 | 697151766SafetyScalpel173 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Kyuan Medical Apparatus Co., Ltd
- EUDAMED SRN
- CN-MF-000021229
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED de092025-a127-4c03-8251-c0accbc292cd 61 fields · synced Jun 19, 2026