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CryOmega

by CryoConcepts, LP

Ref 160-2001Model CryOmega International

CryOmega (160-2001) is a device classified as Class IIa in the EU and Class II in the US made by Cryoconcepts, LP, registered in EUDAMED on 5 Mar 2026 (Basic UDI-DI B-00850077006005), cleared under FDA 510(k) K102006 on 6 Oct 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00850077006005), active as of 22 Oct 2026.

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

CE MDD 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) K102006

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/MDD EUDAMED NumberB-00850077006005 Basic UDI-DI 00850077006005UDI-DIDate5 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850077006005 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK102006 Date6 Oct 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00850077006005 registered 5 Mar 2026 Active
  • FDA 510(k) K102006 decided 6 Oct 2010 Active
  • FDA GUDID UDI-DI 00850077006005 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K102006
  2. Listed FDA GUDID 00850077006005
  3. Registered EUDAMED B-00850077006005

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Cryogenic spray, cutaneous
Device name
CryOmega II
Model / Ref / Catalog
CryOmega International, 160-2001
Primary DI / UDI-DI
00850077006005
Basic UDI-DI
B-00850077006005
510(k) Number
FDA product code
GEH
EMDN code
Z120102 Cryosurgery equipment
GMDN term
Cryogenic spray, cutaneous
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4350
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 16 Gram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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
US-MF-000009822
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)