Identity
- Trade Name
- KOMET EUDAMED
- Device Name
- lames de gouges n°2 Komet - boite de 50 EUDAMED
- Model / Reference
- LAMES DE GOUGE EUDAMED3760245971981 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760245971981 EUDAMED
- Basic UDI-DI
- B-03760245971981 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
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Manual scalpel blade, single-use
Komet by Coblentz Medical Blades Industry — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Manual scalpel blade, single-use.
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- SHARD — APPLIED DENTAL, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760245971981 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coblentz Medical Blades Industry
- EUDAMED SRN
- FR-MF-000010361
Sources (1)
- EUDAMED d406d1f9-f95c-4b32-bdb5-88fa6fa5e679 61 fields · synced Jun 18, 2026