Skip to content

JOBST Opaque 115365

by Bsn Medical SAS

Ref 78488-03

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

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4042809400350948V Basic UDI-DI 00035664153656UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00035664153656 UDI-DI Date17 Oct 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
JOBST® Opaque EUDAMED
JOBST Opaque GUDID
Generic name
Compression/pressure sock/stocking, reusable
Device name
JOBST® Opaque 20-30
Model / Ref / Catalog
78488-03 EUDAMED
115365 GUDID
Primary DI / UDI-DI
00035664153656
Basic UDI-DI
4042809400350948V
FDA product code
DWL
EMDN code
M030405 Compression stockings
GMDN term
Compression/pressure sock/stocking, reusable
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
78488-03
GUDID
115365
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Compression/pressure sock/stocking, reusable

Other devices from Bsn Medical SAS

See all devices from Bsn Medical SAS →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (20)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No