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Urine Profil(E) Antisera Box (Dm)

by sebia

Ref 4338

Urine Profil(E) Antisera Box (Dm) (4338) is a device classified as IVD General made by Sebia, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-03607360043387), active as of 7 Nov 2026.

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03607360043387 Basic UDI-DI 03607360043387UDI-DIDate15 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
4338
Primary DI / UDI-DI
03607360043387
Basic UDI-DI
B-03607360043387
EMDN code
W01029001 Antisera (monovalent and polyvalent)
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000003520

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)