Identity
- Trade Name
- Sterile Disposable Scalpels EUDAMED
- Device Name
- Sterile Disposable Scalpels EUDAMED
- Model / Reference
- No.10S EUDAMEDNo.20S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26971517661627 EUDAMED
- Basic UDI-DI
- 697151766sterilescalpelCR EUDAMED
- Direct Marketing DI
- 26971517661627 EUDAMED
- EMDN Code
- V010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Scalpel, single-use
Sterile Disposable Scalpels by Suzhou Kyuan Medical Apparatus Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697151766sterilescalpelCR | 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 304067a5-0600-4851-a778-f94b3754a803 61 fields · synced Jun 17, 2026