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Autozyme ACL

by Cambridge Life Sciences Ltd 2 variants

Ref Z4696Model IgM

Active European Union

CE IVDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060428440111 Basic UDI-DI 05060428440111UDI-DIDate1 Oct 2026RegisteredStatusActive

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  • Withdrawn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
IgM, Z4696
Primary DI / UDI-DI
05060428440111
Basic UDI-DI
B-05060428440111
EMDN Code
W0102100501 Anti-cardiolipin antibodies
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000026451
Authorised representative
Glenbio Ireland Ltd. IE-AR-000024936

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See all devices from Cambridge Life Sciences Ltd →

Properties

  • Human Tissues
  • Animal Tissues

Other properties (8)

  • Sterile: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No