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truSculpt 16

by Cutera, Inc.

Ref 7001922

truSculpt 16 (7001922) is a device classified as Class IIb in the EU and Class II in the US made by Cutera, Inc., registered in EUDAMED on 5 Nov 2024 (Basic UDI-DI B-00816722022448) and listed in FDA GUDID since 27 Jun 2018 (UDI-DI 00816722022448), active as of 25 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816722022448 Basic UDI-DI 00816722022448UDI-DIDate5 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00816722022448 UDI-DI Date27 Jun 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816722022448 registered 5 Nov 2024 Active
  • FDA GUDID UDI-DI 00816722022448 listed 27 Jun 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816722022448
  2. Registered EUDAMED B-00816722022448

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  • Withdrawn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
truSculpt 16 EUDAMED
truSculpt 16 Hand Held GUDID
Generic name
Radio-frequency skin contouring system applicator, monopolar
Model / reference
7001922 EUDAMED
truSculpt 16 Hand Held GUDID
Primary DI / UDI-DI
00816722022448
Basic UDI-DI
B-00816722022448
FDA product code
GEI, PBX
EMDN code
Z12010999 Electrosurgery instruments - other
GMDN term
Radio-frequency skin contouring system applicator, monopolar
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
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
7001922
GUDID
truSculpt 16 Hand Held
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.

Manufacturer details

EUDAMED SRN
US-MF-000010456
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - OTHER.

Other devices from Cutera, Inc.

  • truSculpt iD

    Class II

  • Titan V

    Class II

  • CoolView

    Class II

  • AviClear

    Class II

See all devices from Cutera, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)