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CROMA Electrosurgical Generator
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 7-EMR-050Ref PRD-EMR-050
by Creo Medical
Identity
- Trade Name
- CROMA Electrosurgical Generator EUDAMED
- Device Name
- CROMA Electrosurgical Generator EUDAMEDCROMA Electrosurgical Generator (PG2.0) EUDAMED
- Model / Reference
- 7-EMR-050 EUDAMEDPRD-EMR-050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060359560506 EUDAMED05060359560698 EUDAMED
- Basic UDI-DI
- B-05060359560506 EUDAMEDB-05060359560698 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
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
CROMA Electrosurgical Generator by Creo Medical — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242983 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-05060359560506 | 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 (3)
- EUDAMED d014eedf-9832-4e2c-8711-0af892d64be0 61 fields · synced Jul 28, 2026
- EUDAMED db8888a4-7a3f-4958-a745-9c63332cc30b 61 fields · synced May 18, 2026
- FDA 510(k) K242983 1 fields · synced May 18, 2026