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Bgi

by Bgi Europe a/S 29 variants

Ref SAI2022016Model 10 tests/kit

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-SAI2022016HX Basic UDI-DI D-SAI2022016HXUDI-DIDate13 May 2022RegisteredStatusActive

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  • Withdrawn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
25-hydroxy vitamin D Determination Kit（Fluorescence Immunochromatographic Assay）
Model / Reference
10 tests/kit, SAI2022016
Primary DI / UDI-DI
D-SAI2022016HX
Basic UDI-DI
B-SAI2022016HX
EMDN Code
W0102060309 25-hydroxyvitamin d
Device Class
Class IVD General
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

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Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No