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Concentrated Wash Buffer

by Virtue Diagnostics (Suzhou) Co., Ltd 2 variants

Ref 12001081

Active European Union

CE IVDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697440255CLIA_CWBuffer98 Basic UDI-DI 06974402553034UDI-DIDate16 Jul 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
12001081
Primary DI / UDI-DI
06974402553034
Basic UDI-DI
697440255CLIA_CWBuffer98
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000013251
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Virtue Diagnostics (Suzhou) Co., Ltd

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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