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Control Positivo En Seco Gdh-Toxins / Dry Gdh-Toxins Positive Control

by Operon, S.A.

Ref 9.065.011.12.000Model 9.065.XXX.12.ZZZ

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8429577906512DH Basic UDI-DI 08429577004808UDI-DIDate13 Mar 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Control Positivo En Seco Gdh-Toxins / Dry Positive Control Gdh-Toxins
Model / Reference
9.065.XXX.12.ZZZ, 9.065.011.12.000
Primary DI / UDI-DI
08429577004808
Basic UDI-DI
8429577906512DH
EMDN Code
W0105080801 Bacteriology controls - inf.imm.
Device Class
Class B
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000004790

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No