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VenoTrain soft S 21280411504334

by Bauerfeind GmbH & Co.

Ref 21280411504334

VenoTrain soft S 21280411504334 is a device classified as Class I in the EU and Class II in the US made by Bauerfeind GmbH & Co., registered in EUDAMED on 23 Apr 2026 (Basic UDI-DI 4046445SOFs00000005D), cleared under FDA 510(k) K860826 on 18 Jun 1986 and listed in FDA GUDID since 30 Sep 2021 (UDI-DI 04057532417963), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K860826

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4046445SOFs00000005D Basic UDI-DI 04057532417963UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04057532417963 UDI-DI Date30 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK860826 Date18 Jun 1986DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4046445SOFs00000005D registered 23 Apr 2026 Active
  • FDA 510(k) K860826 decided 18 Jun 1986 Active
  • FDA GUDID UDI-DI 04057532417963 listed 30 Sep 2021 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K860826
  2. Listed FDA GUDID 04057532417963
  3. Registered EUDAMED 4046445SOFs00000005D

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
VenoTrain soft S, AD, border dot 3cm, Ccl 1, Special heel, closed toe, XL Plus long, Navy EUDAMED
VenoTrain soft S GUDID
Generic name
Compression/pressure sock/stocking, single-use
Model / reference
21280411504334
Primary DI / UDI-DI
04057532417963
Basic UDI-DI
4046445SOFs00000005D
510(k) Number
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
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Compression/pressure sock/stocking, single-use

Cleared under the same submission (K860826)

and 8 more cleared under K860826

Similar devices in this category

Other devices filed under BANDAGES.

Other devices from Bauerfeind GmbH & Co.

See all devices from Bauerfeind GmbH & Co. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)