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Lipoprotein (a) Molarity Assay

by Diazyme Laboratories, Inc. 2 variants

Ref DZ098A-BY1

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0817089024311XA Basic UDI-DI 00817089024465UDI-DIDate24 Jul 2026RegisteredStatusActive

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  • Withdrawn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
Lipoprotein (a) Molarity Assay; Lipoprotein (a) Molarity PCh Assay
Model / Reference
DZ098A-BY1
Primary DI / UDI-DI
00817089024465
Basic UDI-DI
0817089024311XA
EMDN Code
W0102010405 Lipoprotein ( a )
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000025166
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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