Skip to content

CryoMini 4009

by Zimmer MedizinSysteme GmbH

Ref 4009Model CryoMini

CryoMini 4009 is a device classified as Class IIa in the EU and Class II in the US made by Zimmer MedizinSysteme GmbH, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-04053815003083), cleared under FDA 510(k) K080735 on 4 Apr 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04053815003083), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K080735

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04053815003083 Basic UDI-DI 04053815003083UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053815003083 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK080735 Date4 Apr 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04053815003083 registered 16 Sep 2026 Active
  • FDA 510(k) K080735 decided 4 Apr 2008 Active
  • FDA GUDID UDI-DI 04053815003083 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K080735
  2. Listed FDA GUDID 04053815003083
  3. Registered EUDAMED B-04053815003083

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  • Withdrawn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

Trade name
CryoMini
Generic name
Localized cutaneous/musculoskeletal cryotherapy unit
Model / Ref / Catalog
4009, CryoMini
Primary DI / UDI-DI
04053815003083
Basic UDI-DI
B-04053815003083
510(k) Number
FDA product code
GEX
EMDN code
M9001 Cryotherapy and thermotherapy devices
GMDN term
Localized cutaneous/musculoskeletal cryotherapy unit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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.

Related devices

Category: Localized cutaneous/musculoskeletal cryotherapy unit

Cleared under the same submission (K080735)

Similar devices in this category

Other devices filed under CRYOTHERAPY AND THERMOTHERAPY DEVICES.

Other devices from Zimmer Medizinsystems GmbH

See all devices from Zimmer Medizinsystems GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)