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Doff N Donner 583D

by Sigvaris, Inc.

Part of a family of 6 devices: see the family page

Ref 583D100Model DOFF 'N DONNER

Doff N Donner 583D (583D100) is a device classified as Class I in the EU and Class II in the US made by Sigvaris, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 7613378DNDFQ) and listed in FDA GUDID since 5 Dec 2016 (UDI-DI 00745129215989), active (EUDAMED), not in commercial distribution (GUDID) as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7613378DNDFQ Basic UDI-DI 00745129215989UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00745129215989 UDI-DI Date5 Dec 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7613378DNDFQ registered 21 May 2026 Active
  • FDA GUDID UDI-DI 00745129215989 listed 5 Dec 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00745129215989
  2. Registered EUDAMED 7613378DNDFQ

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  • Withdrawn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
Doff 'n Donner EUDAMED
Doff N Donner GUDID
Generic name
Compression/pressure sock/stocking, single-use
Model / Ref / Catalog
DOFF 'N DONNER, 583D100, 583D
Primary DI / UDI-DI
00745129215989
Basic UDI-DI
7613378DNDFQ
FDA product code
DWL
EMDN code
M030405 Compression stockings
GMDN term
Compression/pressure sock/stocking, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.5780
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DOFF 'N DONNER
583D100
GUDID
583D
Device classEUDAMED
Class I
GUDID
Class II

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

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)