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Thermage FLX Eye Tip, 0.25 cm2, 225 REP

by Solta Medical, Inc.

Ref TT0.25F6-225Model Thermage FLX

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081699502B0014WD Basic UDI-DI 00816995021346UDI-DIDate28 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00816995021346 UDI-DI Date14 Dec 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Thermage FLX Eye Tip, 0.25 cm2, 225 REP EUDAMED
Thermage Flx GUDID
Generic Name
Radio-frequency skin/body contouring system
Device Name
Footswitch
Model / Ref / Catalog
Thermage FLX, TT0.25F6-225
Primary DI / UDI-DI
00816995021346
Basic UDI-DI
081699502B0014WD
FDA Product Code
ISA, GEI
EMDN Code
V9015, V9099
GMDN Term
Radio-frequency skin/body contouring system
Device Class
Class I
Regulation Number
890.5660, 878.4400
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000018343
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Solta Medical, Inc.

See all devices from Solta Medical, Inc. →

Properties

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

Other properties (20)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No