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Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage

by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Ref HWTS-RT057FModel 48 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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974849366419 Basic UDI-DI 06974849366419UDI-DIDate29 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
48 tests/kit, HWTS-RT057F
Primary DI / UDI-DI
06974849366419
Basic UDI-DI
B-06974849366419
EMDN Code
W0105900102 Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000012807
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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