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Sterile Disposable Scalpels SPA
EUDAMEDClass IIa (EU MDR)
Ref No.11Model Model: No.10Ref No.15Ref No.23Ref No.20Ref No.12Ref No.10Ref No.22
Identity
- Trade Name
- Sterile Disposable Scalpels SPA EUDAMED
- Device Name
- Sterile Disposable Scalpels EUDAMED
- Model / Reference
- Model: No.10 EUDAMEDNo.11 EUDAMEDNo.15 EUDAMEDNo.23 EUDAMEDNo.20 EUDAMEDNo.12 EUDAMEDNo.10 EUDAMEDNo.22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36971517661969 EUDAMED36971517661990 EUDAMED36971517662041 EUDAMED36971517662010 EUDAMED36971517661976 EUDAMED36971517661952 EUDAMED36971517662034 EUDAMED
- Basic UDI-DI
- 697151766Scalpelcarbons8Z EUDAMED
- Direct Marketing DI
- 36971517661969 EUDAMED36971517661990 EUDAMED36971517662041 EUDAMED36971517662010 EUDAMED36971517661976 EUDAMED36971517661952 EUDAMED36971517662034 EUDAMED
- EMDN Code
- V010102 SCALPELS WITHOUT 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
Category: Scalpel, single-use
Sterile Disposable Scalpels SPA by Suzhou Kyuan Medical Apparatus Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Scalpel, single-use.
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- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
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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 | 697151766Scalpelcarbons8Z | 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 (7)
- EUDAMED 177a3f62-2ab4-4419-b2f7-8ad45a7160f6 61 fields · synced Sep 18, 2026
- EUDAMED 0bf184a0-2ebc-4f5c-a1a2-642a9a47822d 61 fields · synced May 16, 2026
- EUDAMED afa49f38-5c47-4d41-9931-d94b46999dea 61 fields · synced May 17, 2026
- EUDAMED 155b91d4-a29c-4986-b748-02d0ff9c18dd 61 fields · synced May 17, 2026
- EUDAMED 210b833c-87ab-48a2-a82a-a56ad61abdce 61 fields · synced May 17, 2026
- EUDAMED 6acf1751-360a-469f-9d72-5a7a9d915c46 61 fields · synced May 18, 2026
- EUDAMED 32d693d8-b8fa-4852-8530-a5957cdd9924 61 fields · synced May 18, 2026