Identity
- Trade Name
- CROMA EUDAMEDCROMA Electrosurgical Generator FDA UDI
- Generic Name
- Microwave/electrosurgical system generator FDA UDI
- Device Name
- Croma Electrosurgical Generator EUDAMEDThe CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures. FDA UDI
- Model / Reference
- PRD-EMR-050 EUDAMEDFDA UDI
- Description
- The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures. FDA UDI
Identifiers
- Catalog Number
- PRD-EMR-050 FDA UDI
- Primary DI / UDI-DI
- 05060359561206 EUDAMEDFDA UDI
- Basic UDI-DI
- 506035956CROMAGENERAPG1AX EUDAMED
- Direct Marketing DI
- 05060359561206 EUDAMED
- 510(k) Number
- K242983 FDA UDI
- FDA Product Code
- KNS FDA UDIGEI FDA UDINEY FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Microwave/electrosurgical system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI878.4400 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
Croma by Creo Medical — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506035956CROMAGENERAPG1AX | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Creo Medical
- EUDAMED SRN
- GB-MF-000019076
- Authorised Representative
- Creo Medical, S.L.U. ES-AR-000001355
Sources (2)
- EUDAMED 95dd75c3-cc9e-4960-ab34-293261a81712 61 fields · synced May 30, 2026
- FDA UDI eb1a2e6d-8ebc-43c2-a192-a15eee9a263c 37 fields · synced May 30, 2026