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DNlite-IVD103

by Bio Preventive Medicine Corp.

Ref DNlite-IVD103

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-4719879490015D9 Basic UDI-DI D-4719879490015D9UDI-DIDate17 Oct 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  • Withdrawn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
Human uPTM3-DKD ELISA
Model / Reference
DNlite-IVD103
Primary DI / UDI-DI
D-4719879490015D9
Basic UDI-DI
B-4719879490015D9
EMDN Code
W010399 Haematology / haemostasis / immunohaematology / histology / cytology reagents - other
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
TW-MF-000022845
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Bio Preventive Medicine Corp.

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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