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Thermage Total Tip

by Solta Medical, Inc. 3 variants

Ref TTNS3.00E4-1200Model Thermage

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 Number081699502B0001W4 Basic UDI-DI 00850608002421UDI-DIDate27 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00850608002421 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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 Total Tip EUDAMED
Thermage GUDID
Generic Name
Radio-frequency skin contouring system applicator tip
Device Name
Cryogen Canister
Model / Ref / Catalog
Thermage, TTNS3.00E4-1200
Primary DI / UDI-DI
00850608002421
Basic UDI-DI
081699502B0001W4
FDA Product Code
ISA, GEI
EMDN Code
Z12040203 Dermal regeneration equipment
GMDN Term
Radio-frequency skin contouring system applicator tip
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