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OptiLift Updrage Kit

by Pollogen Ltd

Ref 35000510

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

CE MDD

Valid until

Not listed

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

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/MDD EUDAMED NumberB-27290019147668 Basic UDI-DI 27290019147668UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number27290019147668 UDI-DI Date28 Oct 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Optilift Fractional
Generic Name
Radio-frequency skin surface treatment system applicator
Device Name
OptiLift Updrage Kit
Model / Ref / Catalog
35000510, OPTILIFT FRACTIONAL
Primary DI / UDI-DI
27290019147668 EUDAMED
07290019147657 GUDID
Basic UDI-DI
B-27290019147668
FDA Product Code
GEI, NGX
EMDN Code
Z12040285 General medicine therapeutic treatment instruments - consumables
GMDN Term
Radio-frequency skin surface treatment system applicator
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4400, 890.5850
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
35000510
GUDID
OPTILIFT FRACTIONAL
Primary DI / UDI-DIEUDAMED
27290019147668
GUDID
07290019147657
Device ClassEUDAMED
Class IIa
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
IL-MF-000031034
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Pollogen Ltd

See all devices from Pollogen Ltd →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Lot / Batch Number: No
  • Expiration Date: No