Identity
- Trade Name
- CROMA EUDAMED
- Device Name
- Croma Electrosurgical Generator EUDAMED
- Model / Reference
- 7-EMR-050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060359561183 EUDAMED
- Basic UDI-DI
- 506035956CROMAGENERAPG1AX EUDAMED
- Direct Marketing DI
- 05060359561183 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
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
Croma by Creo Medical — Class IIb — 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 | 506035956CROMAGENERAPG1AX | Class IIb | Active |
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Manufacturer
- Manufacturer
- Creo Medical
- EUDAMED SRN
- GB-MF-000019076
- Authorised Representative
- Creo Medical, S.L.U. ES-AR-000001355
Sources (1)
- EUDAMED 77aa1261-f131-4e9a-83ad-2a27fc0d740e 61 fields · synced Jul 10, 2026