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CryoPro Mini

by Cortex Technology Aps

Ref E0200219

CryoPro Mini (E0200219) is a general cryosurgical system (EU MDR Class IIa; FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by Cortex Technology Aps, registered in EUDAMED on 19 Feb 2025 (Basic UDI-DI 5710188020028G), cleared under FDA 510(k) K982280 on 25 Nov 1998 and listed in FDA GUDID since 26 Oct 2016 (UDI-DI 05710188020022), 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) K982280

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 Number5710188020028G Basic UDI-DI 05710188020022UDI-DIDate19 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05710188020022 UDI-DI Date26 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK982280 Date25 Nov 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5710188020028G registered 19 Feb 2025 Active
  • FDA 510(k) K982280 decided 25 Nov 1998 Active
  • FDA GUDID UDI-DI 05710188020022 listed 26 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K982280
  2. Listed FDA GUDID 05710188020022
  3. Registered EUDAMED 5710188020028G

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  • Withdrawn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

Generic name
General cryosurgical system, cryogen gas, mechanical
Model / Ref / Catalog
E0200219, 19
Primary DI / UDI-DI
05710188020022
Basic UDI-DI
5710188020028G
Direct marketing DI
05710188020022
510(k) Number
FDA product code
GEH
EMDN code
Z120102 Cryosurgery equipment
GMDN term
General cryosurgical system, cryogen gas, mechanical
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4350
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
E0200219
GUDID
19
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 05710188020022: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa 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
DK-MF-000002984

Similar devices in this category

Other devices filed under CRYOSURGERY EQUIPMENT.

Other devices from Cortex Technology Aps

See all devices from Cortex Technology Aps →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Reusable
  • Serial number
Other properties (22, all answered No)