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Hantavirus IgG/IgM Antibody Rapid Test Kit

by Shenzhen Reagent Technology Co., Ltd. EUDAMED

Active European Union

Ref RNPT96027-01Model 1T

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974443201819 Basic UDI-DIDate20 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
1T, RNPT96027-01
Primary DI / UDI-DI
06974443201819
Basic UDI-DI
B-06974443201819
EMDN Code
W0105090399 Retroviruses - rt & poc - other
Device Class
Class IVD General
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000047757
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Shenzhen Reagent Technology Co., Ltd.

See all devices from Shenzhen Reagent Technology Co., Ltd. →

Properties

Show properties
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No