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Tixel i HP TiPH0001

by Novoxel Ltd

Ref TiPH0001

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011752TiPH00016P Basic UDI-DI 72901175240093UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number72901175240093 UDI-DI Date6 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Tixel EUDAMED
Tixel i HP GUDID
Generic Name
Eyelid thermal pulsation system applicator, reusable
Model / Reference
TiPH0001
Primary DI / UDI-DI
72901175240093 EUDAMED
07290117524084 GUDID
Basic UDI-DI
729011752TiPH00016P
Direct Marketing DI
72901175240093
FDA Product Code
ORZ
EMDN Code
Z12040218 Endermology treatments
GMDN Term
Eyelid thermal pulsation system applicator, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.5200
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
72901175240093
GUDID
07290117524084
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Novoxel Ltd

See all devices from Novoxel Ltd →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No