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Disposable Surgical Scalpel
EUDAMEDClass IIa (EU MDR)
Ref AN-3-10Model Model: AS-3，AS-3L，AN-3，AN-3L Size: 10, 11, 15
Identity
- Device Name
- Disposable Surgical Scalpel EUDAMED
- Model / Reference
- Model: AS-3，AS-3L，AN-3，AN-3L Size: 10, 11, 15 EUDAMEDAN-3-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934047909658 EUDAMED
- Basic UDI-DI
- 69340479EU06S2 EUDAMED
- EMDN Code
- V010301 BLADES WITH SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 Surgical Scalpel by Ningbo Medsun Medical 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 | 69340479EU06S2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Medsun Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011842
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f64e523d-c2fc-4ee5-a73b-0938a071fb5e 61 fields · synced Jul 22, 2026