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HydraFacial

by Hydrafacial, LLC 4 variants

Ref 7000079-BLKModel 70000079-BLK

HydraFacial (7000079-BLK) is a device classified as Class IIa in the EU and Class I in the US made by Hydrafacial LLC, registered in EUDAMED on 30 Jul 2025 (Basic UDI-DI 081000753SYNB4) and listed in FDA GUDID since 18 Jul 2024 (UDI-DI 00810007532400), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081000753SYNB4 Basic UDI-DI 00810007532400UDI-DIDate30 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810007532400 UDI-DI Date18 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081000753SYNB4 registered 30 Jul 2025 Active
  • FDA GUDID UDI-DI 00810007532400 listed 18 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810007532400
  2. Registered EUDAMED 081000753SYNB4

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  • Withdrawn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
HydraFacial EUDAMED
Hydrafacial Syndeo GUDID
Generic name
Dermabrasion unit
Model / Ref / Catalog
70000079-BLK, 7000079-BLK, 240V Black
Primary DI / UDI-DI
00810007532400
Basic UDI-DI
081000753SYNB4
FDA product code
GFE
EMDN code
Z12040299 General medicine therapeutic treatment instruments - other
GMDN term
Dermabrasion unit
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
70000079-BLK
7000079-BLK
GUDID
240V Black
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000004431
Authorised representative
E C REP LIMITED IE-AR-000003995

Similar devices in this category

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

Other devices from Hydrafacial LLC

See all devices from Hydrafacial LLC →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)