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OptiLift

by Pollogen Ltd

Ref 35000500

OptiLift (35000500) is a device classified as Class IIb in the EU and Class II in the US made by Pollogen Ltd, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI B-07290019147633) and listed in FDA GUDID since 28 Oct 2025 (UDI-DI 07290019147633), 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-07290019147633 Basic UDI-DI 07290019147633UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290019147633 UDI-DI Date28 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07290019147633 registered 4 Aug 2026 Active
  • FDA GUDID UDI-DI 07290019147633 listed 28 Oct 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290019147633
  2. Registered EUDAMED B-07290019147633

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  • Withdrawn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

Generic name
Radio-frequency skin surface treatment/fat liquefaction system control unit
Model / Ref / Catalog
35000500, OptiLift
Primary DI / UDI-DI
07290019147633
Basic UDI-DI
B-07290019147633
FDA product code
GEI, NGX
EMDN code
Z12040299 General medicine therapeutic treatment instruments - other
GMDN term
Radio-frequency skin surface treatment/fat liquefaction system control unit
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400, 890.5850
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
35000500
GUDID
OptiLift
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.

Similar devices in this category

Other devices filed under GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER.

Other devices from Pollogen Ltd

See all devices from Pollogen Ltd →

Properties

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