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SPOTCHEM II Inorganic Phosphorus

by ARKRAY Factory, Inc. 2 variants

Ref 77414

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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-77414JB Basic UDI-DI D-77414JBUDI-DIDate29 Apr 2022RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Model / Reference
77414
Primary DI / UDI-DI
D-77414JB
Basic UDI-DI
B-77414JB
EMDN Code
W01010307 Phosphate inorganic / phosphorus
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
JP-MF-000003008
Authorised representative
ARKRAY Europe, B.V. NL-AR-000002056

Related devices

Category: Inorganic phosphate (PO43-) IVD, reagent

Other devices from ARKRAY Factory, Inc.

See all devices from ARKRAY Factory, Inc. →

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