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V-ST Single Use tip AS47000

by Viora Ltd

Ref AS47000Model V-ST Single use Tips

V-ST Single Use tip AS47000 is a device classified as Class IIb in the EU and Class II in the US made by Viora Ltd, registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-07290016746457), cleared under FDA 510(k) K162363 on 18 Nov 2016 (2 earlier submissions) and listed in FDA GUDID since 3 Jun 2025 (UDI-DI 07290016746457), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162363

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290016746457 Basic UDI-DI 07290016746457UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016746457 UDI-DI Date3 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162363 Date18 Nov 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016746457 registered 24 Jun 2026 Active
  • FDA 510(k) K162363 decided 18 Nov 2016 Active· +2 more in the status table
  • FDA GUDID UDI-DI 07290016746457 listed 3 Jun 2025 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K150035
  2. Cleared FDA 510(k) K152611
  3. Cleared FDA 510(k) K162363
  4. Listed FDA GUDID 07290016746457
  5. Registered EUDAMED B-07290016746457

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
V-ST Single Use tip
Generic name
Multi-modality skin surface treatment system
Device name
V-ST Single use Tips
Model / Ref / Catalog
AS47000, V-ST Single use Tips
Primary DI / UDI-DI
07290016746457
Basic UDI-DI
B-07290016746457
510(k) Number
FDA product code
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
878.4400, 890.5660
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multi-modality skin surface treatment system

Cleared under the same submission (K150035)

and 2 more cleared under K150035

Cleared under the same submission (K152611)

and 8 more cleared under K152611

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Viora Ltd

See all devices from Viora Ltd →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)