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V-FR Handpiece V-FR2002

by Viora Ltd

Ref V-FR2002Model V-FR Handpiece

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290016746402 Basic UDI-DI 07290016746402UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016746402 UDI-DI Date19 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
V-FR Handpiece
Generic Name
Multi-modality skin surface treatment system
Model / Reference
V-FR2002, V-FR Handpiece
Primary DI / UDI-DI
07290016746402
Basic UDI-DI
B-07290016746402
510(k) Number
FDA Product Code
GEX, PBX, ISA
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Multi-modality skin surface treatment system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810, 878.4400, 890.5660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Related devices

Cleared under the same submission (K201064)

Other devices from Viora Ltd

See all devices from Viora Ltd →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Lot / Batch Number: No
  • Expiration Date: No