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Optochin

by Bio-Rad

Ref 53852

Optochin (53852) is a device classified as IVD General made by Bio-Rad, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-03610520000502), 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-03610520000502 Basic UDI-DI 03610520000502UDI-DIDate22 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  • Withdrawn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
53852
Primary DI / UDI-DI
03610520000502
Basic UDI-DI
B-03610520000502
EMDN code
W0104080502 Impregnated disks, multi-disks & tablets
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000006261

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)