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Croma

by Creo Medical 2 variants

Ref PRD-EMR-050

Croma (PRD-EMR-050) is a microwave/electrosurgical system generator (EU MDR Class IIb; FDA Class II) made by Creo Medical, registered in EUDAMED on 16 May 2025 (Basic UDI-DI 506035956CROMAGENERAPG1AX), cleared under FDA 510(k) K242983 on 5 Feb 2025 and listed in FDA GUDID since 10 Feb 2025 (UDI-DI 05060359561206), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242983

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506035956CROMAGENERAPG1AX Basic UDI-DI 05060359561206UDI-DIDate16 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060359561206 UDI-DI Date10 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK242983 Date5 Feb 2025IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506035956CROMAGENERAPG1AX registered 16 May 2025 Active
  • FDA 510(k) K242983 decided 5 Feb 2025 Active
  • FDA GUDID UDI-DI 05060359561206 listed 10 Feb 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K242983
  2. Listed FDA GUDID 05060359561206
  3. Registered EUDAMED 506035956CROMAGENERAPG1AX

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Croma EUDAMED
CROMA Electrosurgical Generator GUDID
Generic name
Microwave/electrosurgical system generator
Model / Ref / Catalog
PRD-EMR-050
Primary DI / UDI-DI
05060359561206
Basic UDI-DI
506035956CROMAGENERAPG1AX
Direct marketing DI
05060359561206
510(k) Number
FDA product code
KNS, GEI, NEY
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Microwave/electrosurgical system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.4300, 878.4400
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
GB-MF-000019076
Authorised representative
Creo Medical, S.L.U. ES-AR-000001355

Related devices

Category: Foot-switch, electrical

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Creo Medical

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)