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WAW Duo FUE Product line

by Devroye Instruments SRL 6 variants

Ref External Sleeve Support Box

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 Number05430003362051 UDI-DI Date9 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number54300033620WDFSystem69 Basic UDI-DI 05430003362051UDI-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  • Withdrawn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

Trade Name
External Sleeve Support Box
Generic Name
Electrosurgical handpiece, reusable
Device Name
WAW Duo FUE Product line
Model / Reference
External Sleeve Support Box EUDAMED
1 GUDID
Primary DI / UDI-DI
05430003362051
Basic UDI-DI
54300033620WDFSystem69
Direct Marketing DI
05430003362051
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
External Sleeve Support Box
GUDID
1
Contains LatexEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
BE-MF-000034423

Other devices from Devroye Instruments SRL

See all devices from Devroye Instruments SRL →

Properties

  • Contains Latex NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No