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SARS-CoV-2 Antigen Rapid Qualitative Test

by Qingdao Huaren Medical Product Co., Ltd. 2 variants

Ref 50 tests/kit, 10 tests/kit, 1 test/kit, 25 tests/kit, 20 tests/kit, 5 tests/kit

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-16971760720112 Basic UDI-DI Date23 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
SARS-CoV-2 Antigen Rapid Qualitative Test
Model / Reference
50 tests/kit, 10 tests/kit, 1 test/kit, 25 tests/kit, 20 tests/kit, 5 tests/kit
Primary DI / UDI-DI
16971760720112, 06971760720115, 16971760720082, 06971760720061, 06971760720108, 16971760720105, 16971760720068, 06971760720092, 16971760720075, 16971760720099, 06971760720085
Basic UDI-DI
B-16971760720112, B-06971760720115, B-16971760720082, B-06971760720061, B-06971760720108, B-16971760720105, B-16971760720068, B-06971760720092, B-16971760720075, B-16971760720099, B-06971760720085
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000028417
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Qingdao Huaren Medical Product Co., Ltd.

Properties

  • Sterile
  • Reagent
  • Professional Testing

Other properties (7)

  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No