Skip to content

Monkeypox Antibody Rapid Test (Whole blood/Serum/Plasma)

by Zhejiang Anji Saianfu Biotechnology Co., Ltd. China EUDAMED

Ref 3027102

EMDN W0105099008

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69743840309508 Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
3027102
Primary DI / UDI-DI
69743840309508
Basic UDI-DI
B-69743840309508
EMDN Code
W0105099008 Monkeypox virus / mpox rt & poc
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000045029
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhejiang Anji Saianfu Biotechnology Co., Ltd.

See all devices from Zhejiang Anji Saianfu Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c463e1e9-de0d-42e9-8ee0-972d35ea72ae 61 fields · synced 22 Oct 2026