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Xerf 2.0(USA_100V)

by Cynosure Lutronic Technology Corporation

Ref XERF

Xerf 2.0(USA_100V) is a device classified as Class IIb in the EU and Class II in the US made by Cynosure Lutronic Technology Corporation, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 88002918211011AGV) and listed in FDA GUDID since 8 Apr 2026 (UDI-DI 08800291821382), active as of 9 Nov 2026.

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

CE MDR

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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88002918211011AGV Basic UDI-DI 08800291821382UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800291821382 UDI-DI Date8 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88002918211011AGV registered 22 Jun 2026 Active
  • FDA GUDID UDI-DI 08800291821382 listed 8 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800291821382
  2. Registered EUDAMED 88002918211011AGV

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  • Withdrawn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
Xerf
Generic name
Radio-frequency skin/body contouring system
Device name
Electrosurgical unit
Model / reference
XERF EUDAMED
XERF 2.0(USA_100V) GUDID
Primary DI / UDI-DI
08800291821382
Basic UDI-DI
88002918211011AGV
FDA product code
GEI
EMDN code
X0599 High intensity electromagnetic radiation emitting equipment without an intended medical purpose intended for use on the human body, for skin resurfacing, tattoo or hair removal or other skin treatment – other
GMDN term
Radio-frequency skin/body contouring system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
XERF
GUDID
XERF 2.0(USA_100V)
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 HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER.

Other devices from Cynosure Lutronic Technology Corporation

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)