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Kovacs

by Bio-Rad

Ref 55313

Kovacs (55313) is a Class A device made by Bio-Rad, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 361052A003057U), active as of 7 Nov 2026.

Active European Union

CE IVDR

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/IVDR Number361052A003057U Basic UDI-DI 03610520000687UDI-DIDate2 Nov 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device name
Demonstration of indole production - Vial
Model / reference
55313
Primary DI / UDI-DI
03610520000687
Basic UDI-DI
361052A003057U
EMDN code
W0104080299 Manual identification - other
Device class
Class A
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000006261

Similar devices in this category

Other devices filed under MANUAL IDENTIFICATION - OTHER.

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Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (10, all answered No)