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Normal Control (5) 4785

by Sebia

Ref 4785

Normal Control (5) 4785 is a device classified as IVD General (EU), Class I (US) made by Sebia, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-03607360047859) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 03607360047859), active as of 12 Nov 2026.

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

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-03607360047859 Basic UDI-DI 03607360047859UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03607360047859 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03607360047859 registered 15 Oct 2026 Active
  • FDA GUDID UDI-DI 03607360047859 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03607360047859
  2. Registered EUDAMED B-03607360047859

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Normal Control (5)
Generic name
Protein electrophoresis IVD, control
Model / Ref / Catalog
4785
Primary DI / UDI-DI
03607360047859
Basic UDI-DI
B-03607360047859
FDA product code
JJY
EMDN code
W0101050101 Assayed multicomponent controls (cc)
GMDN term
Protein electrophoresis IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

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

Related devices

Category: Protein electrophoresis IVD, control

Similar devices in this category

Other devices filed under ASSAYED MULTICOMPONENT CONTROLS (CC).

Other devices from Sebia

See all devices from Sebia →

Properties

  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)