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Profound Matrix FG71841

by Candela Corporation

Ref FG71841 / Profound MatrixModel Profound Matrix

Profound Matrix FG71841 is a device classified as Class IIb in the EU and Class II in the US made by Candela Corporation, registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 0817495028505109616HW) and listed in FDA GUDID since 15 Sep 2022 (UDI-DI 00817495023724), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0817495028505109616HW Basic UDI-DI 00817495023724UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817495023724 UDI-DI Date15 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0817495028505109616HW registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 00817495023724 listed 15 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817495023724
  2. Registered EUDAMED 0817495028505109616HW

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  • Withdrawn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
Profound Matrix
Generic name
Multi-modality skin surface treatment system
Device name
Profound Matrix / FG71841
Model / reference
Profound Matrix EUDAMED
FG71841 / Profound Matrix EUDAMED
FG71841 GUDID
Primary DI / UDI-DI
00817495023724
Basic UDI-DI
0817495028505109616HW
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
Multi-modality skin surface treatment system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Profound Matrix
FG71841 / Profound Matrix
GUDID
FG71841
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.

Related devices

Category: Multi-modality skin surface treatment system

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 devices from Candela Corporation

See all devices from Candela Corporation →

Properties

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