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Evkoma
EUDAMEDClass IIa (EU MDR)
Ref Standard CS #11 10-0211 Ref Standard CS #10 10-0110 Ref Standard CS #20 10-0120 Ref Standard CS #22 10-0122 Ref Standard CS #15 10-0115
Identity
- Trade Name
- EVKOMA EUDAMED
- Device Name
- Disposable Surgical Blades EUDAMED
- Model / Reference
- Standard CS #11 10-0211 EUDAMEDStandard CS #10 10-0110 EUDAMEDStandard CS #20 10-0120 EUDAMEDStandard CS #22 10-0122 EUDAMEDStandard CS #15 10-0115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630137423 EUDAMED16945630137416 EUDAMED16945630137447 EUDAMED16945630137461 EUDAMED16945630137430 EUDAMED
- Basic UDI-DI
- 6945630110BA EUDAMED
- Unit of Use DI
- 06945630137426 EUDAMED06945630137419 EUDAMED06945630137440 EUDAMED06945630137464 EUDAMED06945630137433 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
- Bulgaria 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
Evkoma by Sterilance Medical (Suzhou) Inc. — 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
- Bard-Parker ® Carbon Rib-Back Blades — Aspen Surgical Products, Inc. · Class I
- Swann-Morton — Swann-Morton Ltd · Class IIa
- 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 | 6945630110BA | 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 (5)
- EUDAMED 7256e53c-3fbe-4190-b053-d6ae06bb42b2 61 fields · synced Aug 2, 2026
- EUDAMED b29fce8d-b8bf-45ae-a93e-d451ba43b93a 61 fields · synced May 16, 2026
- EUDAMED f01c3852-70e8-42da-b0c9-0ffbf298dfc5 61 fields · synced May 18, 2026
- EUDAMED 21382c6f-6c74-40ba-8343-30d1f71db1a2 61 fields · synced May 18, 2026
- EUDAMED b2a60286-149d-4458-b981-d22e6e9df054 61 fields · synced May 19, 2026