Skip to content

Biosynex

by Chembio Biosynex Diagnostics (Hangzhou) Inc. 3 variants

Ref 860061Model Midstream

Active European Union

CE IVDR

Valid until

17 Jun 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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/IVDR Number697700588C00001OZG Basic UDI-DI 06977005880033UDI-DIDate9 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Simply Pregnancy Test
Model / Reference
Midstream, 860061
Primary DI / UDI-DI
06977005880033
Basic UDI-DI
697700588C00001OZG
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000039047
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Chembio Biosynex Diagnostics (Hangzhou) Inc.

  • Biosynex

    Class B

  • Biosynex

    Class B

Properties

  • Reagent
  • Self Testing

Other properties (9)

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