Identity
- Trade Name
- Sterile Surgical Blades EUDAMED
- Device Name
- Sterile Surgical Blades EUDAMED
- Model / Reference
- No.10S EUDAMEDNo.21S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26971517661245 EUDAMED
- Basic UDI-DI
- 697151766surgicalblades5D EUDAMED
- Direct Marketing DI
- 26971517661245 EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES 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: Manual scalpel blade, single-use
Sterile Surgical Blades by Suzhou Kyuan Medical Apparatus Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual scalpel blade, single-use.
- Paramount — Paramount Surgimed Limited · Class IIa
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- SHARD — APPLIED DENTAL, INC. · Class I
- Sterile Stainless Blades — Southmedic Incorporated · Class I
- Paramount — Paramount Surgimed Limited · Class IIa
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · 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 | 697151766surgicalblades5D | 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 215f31fc-1e0c-47f4-a3ae-64d3193373ac 61 fields · synced Jun 18, 2026