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MP Diagnostics ASSURE HEV lgM Rapid Test

by MP Biomedicals Asia Pacific Pte Ltd

Ref 43160-020

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-08887581000702 Basic UDI-DI 08887581000702UDI-DIDate21 Apr 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  • Withdrawn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

Model / Reference
43160-020
Primary DI / UDI-DI
08887581000702
Basic UDI-DI
B-08887581000702
EMDN Code
W0105090299 Hepatitis viruses - rt & poc - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
SG-MF-000024819
Authorised representative
MP Biomedicals Germany GmbH DE-AR-000020992

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Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (4)

  • Sterile: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No