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Vitassay Pancreatic Elastase Turbidimetric Assay

by Vitassay Healthcare S.L.U

Ref 7115005

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-08436592688852 Basic UDI-DI 08436592688852UDI-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  • Withdrawn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

Device Name
Pancreatic Elastase Turbidimetric Assay
Model / Reference
7115005
Primary DI / UDI-DI
08436592688852
Basic UDI-DI
B-08436592688852
EMDN Code
W0102019006 Trypsin-a1-antitrypsin (elastase)
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
ES-MF-000030959

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Companion Diagnostics

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No