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ALP - Fosfatasi Alc./Alk. Phosphatase (DGKC)

by Sanymed s.a.s. 9 variants

Ref CAE054

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-08056216730240 Basic UDI-DI 08056216730240UDI-DIDate8 Sep 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  • Withdrawn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
ALP - Fosfatasi Alc./Alk. Phosphatase (DGKC) SA2000 R1:4x30mL + R2:2x15mL - 450 Test
Model / Reference
CAE054
Primary DI / UDI-DI
08056216730240
Basic UDI-DI
B-08056216730240
EMDN Code
W01010105 Alkaline phosphatase - total
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026483

Other devices from Sanymed s.a.s.

See all devices from Sanymed s.a.s. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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