← Back to catalogue
Sterile Disposable Scalpels
EUDAMEDClass IIa (EU MDR)
Ref No.15Model Model: No.10
Identity
- Trade Name
- Sterile Disposable Scalpels EUDAMED
- Device Name
- Sterile Disposable Scalpels EUDAMED
- Model / Reference
- Model: No.10 EUDAMEDNo.15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26971517661399 EUDAMED
- Basic UDI-DI
- 697151766Scalpelcarbons8Z EUDAMED
- Direct Marketing DI
- 26971517661399 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 by Suzhou Kyuan Medical Apparatus Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel, single-use.
- MANI ENT Knife — MANI, INC. · Class I
- Unique Edge — Unique Technologies, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Bard-Parker ® Disposable Scalpels — Aspen Surgical Products, Inc. · Class I
- Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Stylus — Surgical Specialties México, S. de R.L. de C.V. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
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 0e13f51f-189c-4e24-943a-a06d77712165 61 fields · synced Jun 18, 2026