Skip to content

COVID-19 Nucleic Acid Rapid Test

by Shanghai GeneSc Biotech Co., Ltd. China EUDAMED

Ref GZ-SC1Model GE-RC4 EMDN W01050499

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975412190080 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  • Withdrawn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 23 Oct 2026

Device Name
Home-Lab
Model / Reference
GE-RC4, GZ-SC1
Primary DI / UDI-DI
06975412190080
Basic UDI-DI
B-06975412190080
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 c78f32a2-ad20-427b-8126-ede8f20216e3 61 fields · synced 23 Oct 2026