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COVID-19 Nucleic Acid Rapid Test

by Shanghai GeneSc Biotech Co., Ltd. China EUDAMED

Ref GZ-SC4Model GE-RC4 EMDN W01050499

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975412190097 Basic UDI-DIDate14 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  • Withdrawn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 22 Oct 2026

Device Name
Home-Lab
Model / Reference
GE-RC4, GZ-SC4
Primary DI / UDI-DI
06975412190097
Basic UDI-DI
B-06975412190097
EMDN Code
W01050499 Virology reagents - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000029293
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai GeneSc Biotech 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 31e68e07-3c99-4cce-8966-5d5db3828cba 61 fields · synced 22 Oct 2026