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Optochin Test

by bioMérieux SA

Ref 544053

Optochin Test (544053) is a Class A device made by Biomerieux SA, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 357302BUDI000495U3), 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 Number357302BUDI000495U3 Basic UDI-DI 03573026653101UDI-DIDate30 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / reference
544053
Primary DI / UDI-DI
03573026653101
Basic UDI-DI
357302BUDI000495U3
Unit of use DI
03573026600204
EMDN code
W0104080502 Impregnated disks, multi-disks & tablets
Device class
Class A
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000004436

Similar devices in this category

Other devices filed under IMPREGNATED DISKS, MULTI-DISKS & TABLETS.

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Properties

  • Reagent
  • Professional testing
Other properties (11, all answered No)