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Disposable Virus Sampling Collector

by Biobase Scientific (Shandong) Co., Ltd 10 variants

Ref KY001

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697313152KY001C5 Basic UDI-DI Date2 Jan 2023RegisteredStatusActive

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  • Withdrawn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
KY001
Primary DI / UDI-DI
06973131520539, 06973131520720, 06973131520881, 06973131520430, 06973131521000, 06973131521222, 06973131521123, 06973131520676, 06973131520744, 06973131520591, 06973131520942, 06973131520355, 06973131520799, 06973131520898, 06973131520768, 06973131521215, 06973131520928, 06973131521031, 06973131520508, 06973131520362, 06973131520393, 06973131520812, 06973131520935, 06973131520805, 06973131520843, 06973131520904, 06973131520775, 06973131520423, 06973131521253, 06973131521062, 06973131520867, 06973131521239, 06973131520461, 06973131520997, 06973131520683, 06973131520522, 06973131520751, 06973131521178, 06973131521130, 06973131520645, 06973131520607, 06973131520980, 06973131520577, 06973131521161, 06973131521024, 06973131521154
Basic UDI-DI
697313152KY001C5
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000011660
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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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