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CryOmega

by CryoConcepts, LP

Ref 160-2004Model CryOmega International - Twin Pack510(k) K172769

CryOmega (160-2004) is a device classified as Class IIa in the EU and Class II in the US made by Cryoconcepts, LP, registered in EUDAMED on 9 Mar 2026 (Basic UDI-DI B-00850077006463) and cleared under FDA 510(k) K172769 on 30 Nov 2017, active as of 25 Oct 2026.

Active European Union and United States

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172769↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850077006463 Basic UDI-DI 00850077006463UDI-DIDate9 Mar 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK172769 Date30 Nov 2017ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850077006463 registered 9 Mar 2026 Active
  • FDA 510(k) K172769 decided 30 Nov 2017 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K172769
  2. Registered EUDAMED B-00850077006463

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device name
CryOmega II
Model / reference
CryOmega International - Twin Pack, 160-2004
Primary DI / UDI-DI
00850077006463
Basic UDI-DI
B-00850077006463
510(k) Number
FDA product code
GEH
EMDN code
Z120102 Cryosurgery equipment
Device class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4350
EU registration type
Legacy device (under a directive)
EU market of registration
Czechia
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIa
510(k)
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

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

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Properties

Other properties (12, all answered No)