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Clatuu Alpha

by Classys

Ref CL5-M500

Clatuu Alpha (CL5-M500) is a Class IIa device made by CLASSYS Inc., registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-08800016901023), active as of 23 Oct 2026.

Active European Union

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800016901023 Basic UDI-DI 08800016901023UDI-DIDate16 Jun 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Cooling Therapeutic Equipment
Model / reference
CL5-M500
Primary DI / UDI-DI
08800016901023
Basic UDI-DI
B-08800016901023
EMDN code
M9001 Cryotherapy and thermotherapy devices
Device class
Class IIa
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000010116
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Similar devices in this category

Other devices filed under CRYOTHERAPY AND THERMOTHERAPY DEVICES.

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

Other properties (12, all answered No)