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VenoTrain soft S 21280411424230

by Bauerfeind GmbH & Co.

Ref 21280411424230

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4046445SOFs00000005D Basic UDI-DI 04057532501501UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04057532501501 UDI-DI Date19 May 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
VenoTrain soft S, AD, border dot 3cm, Ccl 1, Special heel, open toe, XS Normal long, Amaretto EUDAMED
VenoTrain soft S GUDID
Generic Name
Compression/pressure sock/stocking, single-use
Model / Reference
21280411424230
Primary DI / UDI-DI
04057532501501
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 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

Related devices

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

Cleared under the same submission (K860826)

Show all (12)

Other devices from Bauerfeind GmbH & Co.

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Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No