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Disposable Scalpels
EUDAMEDClass IIa (EU MDR)
Ref 07-0110 Disposable Scalpel No.10Ref Asurity 24#Ref 25-0115 Sterile Disposable Scalpels NO. 15Ref 07-0311 Disposable Scalpel No.12Ref 22-0315 Disposable Scalpels No.15Ref 22-0311 Disposable Scalpels No.11Ref 25-0218 Sterile Disposable Scalpels NO. 18Ref 07-0224 Disposable Scalpel No.24Ref 07-0115 Disposable Scalpel No.15Ref 25-0236 Sterile Disposable Scalpels NO. 36Ref 16-0311 Disposable Scalpel MiniⅠ No.11Ref 25-0221 Sterile Disposable Scalpels NO. 21Ref 25-0222 Sterile Disposable Scalpels NO. 22Ref Asurity 18#Ref 25-0220 Sterile Disposable Scalpels NO. 20
Identity
- Device Name
- Disposable Scalpels EUDAMED
- Model / Reference
- 07-0110 Disposable Scalpel No.10 EUDAMEDAsurity 24# EUDAMED25-0115 Sterile Disposable Scalpels NO. 15 EUDAMED07-0311 Disposable Scalpel No.12 EUDAMED22-0315 Disposable Scalpels No.15 EUDAMED22-0311 Disposable Scalpels No.11 EUDAMED25-0218 Sterile Disposable Scalpels NO. 18 EUDAMED07-0224 Disposable Scalpel No.24 EUDAMED07-0115 Disposable Scalpel No.15 EUDAMED25-0236 Sterile Disposable Scalpels NO. 36 EUDAMED16-0311 Disposable Scalpel MiniⅠ No.11 EUDAMED25-0221 Sterile Disposable Scalpels NO. 21 EUDAMED25-0222 Sterile Disposable Scalpels NO. 22 EUDAMEDAsurity 18# EUDAMED25-0220 Sterile Disposable Scalpels NO. 20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630118200 EUDAMED16945630138994 EUDAMED16945630116411 EUDAMED16945630118217 EUDAMED16945630118286 EUDAMED16945630118279 EUDAMED16945630116428 EUDAMED16945630118255 EUDAMED16945630118224 EUDAMED16945630116480 EUDAMED16945630118262 EUDAMED16945630116442 EUDAMED16945630116459 EUDAMED16945630138987 EUDAMED16945630116435 EUDAMED
- Basic UDI-DI
- 6945630107BM EUDAMED6945630103BD EUDAMED6945630122BH EUDAMED6945630116BN EUDAMED
- Unit of Use DI
- 06945630118203 EUDAMED06945630138997 EUDAMED06945630116414 EUDAMED06945630118210 EUDAMED06945630118289 EUDAMED06945630118272 EUDAMED06945630116421 EUDAMED06945630118258 EUDAMED06945630118227 EUDAMED06945630116483 EUDAMED06945630118265 EUDAMED06945630116445 EUDAMED06945630116452 EUDAMED06945630138980 EUDAMED06945630116438 EUDAMED
- EMDN Code
- V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDGermany 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 Scalpels by Sterilance Medical (Suzhou) Inc. — 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 | 6945630107BM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (15)
- EUDAMED 1bda8e50-6334-4c00-bf8e-f238020b8ec6 61 fields · synced Sep 18, 2026
- EUDAMED 86030673-812b-47e0-a8ab-5bf689989b37 61 fields · synced May 11, 2026
- EUDAMED a0ae7d37-29a0-45a1-806e-e0ea9893401f 61 fields · synced May 11, 2026
- EUDAMED ca613e29-46a5-411e-ab67-5f982efeba8d 61 fields · synced May 16, 2026
- EUDAMED 4be04eb5-2a80-4f2e-92f6-dbe1bf1b0157 61 fields · synced May 16, 2026
- EUDAMED 68e9ee4d-08c2-4618-8105-e05e7b352422 61 fields · synced May 17, 2026
- EUDAMED 2468dfdb-f3a9-4a87-b096-723f771b5564 61 fields · synced May 17, 2026
- EUDAMED 5792b333-0fa4-49ee-8be9-84fd026e1100 61 fields · synced May 18, 2026
- EUDAMED 06ef1f1b-a9a7-4b7b-83d3-856a2e08fb6a 61 fields · synced May 18, 2026
- EUDAMED f7553b34-977f-4718-99ef-cb725428de6e 61 fields · synced May 18, 2026
- EUDAMED a5567bbd-1256-416f-9be8-199f326cea4f 61 fields · synced May 18, 2026
- EUDAMED fe69376f-3bca-4999-84b2-c5c77ab17409 61 fields · synced May 18, 2026
- EUDAMED 31c0c18e-d2ed-468b-b868-3a1f25fee3a3 61 fields · synced May 18, 2026
- EUDAMED 77eb5014-dd65-4469-bc42-24cb06502bfa 61 fields · synced May 19, 2026
- EUDAMED e746d0c6-794f-414b-940c-af942f6b7d34 61 fields · synced May 19, 2026