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Breath Sampling Vial

by Zhejiang ALWSCI Technologies Co., Ltd. China EUDAMED

Ref C0002011

EMDN W0503010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697583867ALWCI12NCNEJS Basic UDI-DIDate17 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
C0002011
Primary DI / UDI-DI
16095672020112
Basic UDI-DI
697583867ALWCI12NCNEJS
Unit of Use DI
06095672020115
EMDN Code
W0503010101 Samples analyses, glass tubes
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000030658
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED e683000c-31c5-4298-832b-4959faca4578 61 fields · synced 22 Oct 2026