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Cryokleen

by Sixtem Life Srl 2 variants

Ref CRY0003

Cryokleen (CRY0003) is a Class IIa device made by Sixtem Life Srl, registered in EUDAMED on 18 Oct 2023 (Basic UDI-DI 803277984CRYOKLEEN5J), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803277984CRYOKLEEN5J Basic UDI-DI 08032779840800UDI-DIDate18 Oct 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Trattamento Crioterapico Cheratosi 50ml
Model / reference
CRY0003
Primary DI / UDI-DI
08032779840800
Basic UDI-DI
803277984CRYOKLEEN5J
EMDN code
M9001 Cryotherapy and thermotherapy devices
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022977

Related devices

Category: Hot/cold therapy pack, reusable

Similar devices in this category

Other devices filed under CRYOTHERAPY AND THERMOTHERAPY DEVICES.

Other devices from Sixtem Life Srl

See all devices from Sixtem Life Srl →

Properties

Other properties (14, all answered No)