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Tixel C

by Novoxel Ltd.

Ref MSTX0002

Tixel C (MSTX0002) is a thermo-mechanical skin surface treatment system (EU MDR Class IIa; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Novoxel Ltd, registered in EUDAMED on 13 Oct 2021 (Basic UDI-DI 729011752MSTX0002YL), cleared under FDA 510(k) K202988 on 25 Feb 2021 and listed in FDA GUDID since 14 Nov 2021 (UDI-DI 07290117520055), active as of 22 Oct 2026.

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

CE MDR 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) K202988

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07290117520055 UDI-DI Date14 Nov 2021ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number729011752MSTX0002YL Basic UDI-DI 07290117520055UDI-DIDate13 Oct 2021RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202988 Date25 Feb 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729011752MSTX0002YL registered 13 Oct 2021 Active
  • FDA 510(k) K202988 decided 25 Feb 2021 Active
  • FDA GUDID UDI-DI 07290117520055 listed 14 Nov 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202988
  2. Registered EUDAMED 729011752MSTX0002YL
  3. Listed FDA GUDID 07290117520055

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Thermo-mechanical skin surface treatment system
Model / reference
MSTX0002
Primary DI / UDI-DI
07290117520055 EUDAMED
07290117524046 GUDID
Basic UDI-DI
729011752MSTX0002YL
Direct marketing DI
07290117520055
510(k) Number
FDA product code
GEI
EMDN code
Z12040203, Z12040218
GMDN term
Thermo-mechanical skin surface treatment system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
07290117520055
GUDID
07290117524046
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists 07290117520055; FDA GUDID lists 07290117524046), so their flags are not compared. 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
IL-MF-000008897
Authorised representative
mdi Europa GmbH DE-AR-000006218

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Properties

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