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EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)

by Jiangsu Mole Bioscience Co., LTD. China EUDAMED

Ref E011T100B0C1 EMDN W0105040502

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970895477130 Basic UDI-DIDate8 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
Model / Reference
E011T100B0C1
Primary DI / UDI-DI
06970895477130
Basic UDI-DI
B-06970895477130
EMDN Code
W0105040502 Enterovirus - na reagents
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000001539
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangsu Mole Bioscience Co., LTD.

See all devices from Jiangsu Mole Bioscience Co., LTD. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 664b0589-1845-4af5-ac0d-7e7fee8bba2e 61 fields · synced 24 Oct 2026