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WAW Duo FUE System

by Devroye Instruments SRL

Ref WAW Duo FUE System v2

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

CE MDR

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
United StatesGUDID listing GUDID Number05430003362259 UDI-DI Date21 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number54300033620WDFSystem69 Basic UDI-DI 05430003362259UDI-DIDate13 Oct 2023RegisteredStatusActive

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Electrosurgical handpiece, reusable
Model / Reference
WAW Duo FUE System v2 EUDAMED
2 GUDID
Primary DI / UDI-DI
05430003362259
Basic UDI-DI
54300033620WDFSystem69
Direct Marketing DI
05430003362259
FDA Product Code
GEY
EMDN Code
L0318 Instruments for support of surgical devices, reusable
GMDN Term
Electrosurgical handpiece, reusable
Device Class
Class I
Regulation Number
878.4820
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
WAW Duo FUE System v2
GUDID
2

Manufacturer details

EUDAMED SRN
BE-MF-000034423

Other devices from Devroye Instruments SRL

See all devices from Devroye Instruments SRL →

Properties

  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No