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ST Single Use Tip AS47010

by Viora Ltd

Ref ST Single Use Tip

ST Single Use Tip AS47010 is a device classified as Class IIa in the EU and Class I in the US made by Viora Ltd, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI B-07290016746433), cleared under FDA 510(k) K090221 on 1 Jul 2009 and listed in FDA GUDID since 3 Jun 2025 (UDI-DI 07290016746433), 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) K090221

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290016746433 Basic UDI-DI 07290016746433UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016746433 UDI-DI Date3 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090221 Date1 Jul 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016746433 registered 26 Jun 2026 Active
  • FDA 510(k) K090221 decided 1 Jul 2009 Active
  • FDA GUDID UDI-DI 07290016746433 listed 3 Jun 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090221
  2. Listed FDA GUDID 07290016746433
  3. Registered EUDAMED B-07290016746433

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  • Withdrawn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
ST Single Use Tip
Generic name
Radio-frequency skin/body contouring system
Model / Ref / Catalog
ST Single Use Tip EUDAMED
AS47010 GUDID
Primary DI / UDI-DI
07290016746433
Basic UDI-DI
B-07290016746433
510(k) Number
FDA product code
ISA, NUV
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Radio-frequency skin/body contouring system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
890.5660, 878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ST Single Use Tip
GUDID
AS47010
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Radio-frequency skin/body contouring system

Cleared under the same submission (K090221)

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)