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Singclean®

by Hangzhou Singclean Medical Products Co., Ltd. China EUDAMED

Ref MPV-02-20tModel 20 tests/box

EMDN W0105040532

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936020115384 Basic UDI-DIDate29 Dec 2025RegisteredStatusActive

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

Device Name
Monkeypox virus Antigen Test Kit (Immunochromatography)
Model / Reference
20 tests/box, MPV-02-20t
Primary DI / UDI-DI
06936020115384
Basic UDI-DI
B-06936020115384
EMDN Code
W0105040532 Monkeypox virus / mpox - na reagent
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014098
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Singclean Medical Products Co., Ltd.

  • Singclean®

    Class B

  • Earlibird®

    Class B

  • Validcheck®

    Class B

  • Pretthyal®

    Class III

  • Pepino®

    Class B

  • Singclean®

    Class B

See all devices from Hangzhou Singclean Medical Products Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c28ef7ef-dd13-41f3-97df-47dfc8eb2199 61 fields · synced 22 Oct 2026