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Breath Sampling Vial

by Zhejiang ALWSCI Technologies Co., Ltd. EUDAMED

Active European Union

Ref C0003565Model C0003346, C0003186, C0003507, C0002598, C0003560, C0003561, C0003562, C0003563, C0003564, C0003565, C0003566, C0003567, C0003568, C0003569, C0003570, C0003571

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697583867ALWSCI12BTVVN Basic UDI-DIDate29 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Breath Sampling Vial
Model / Reference
C0003346, C0003186, C0003507, C0002598, C0003560, C0003561, C0003562, C0003563, C0003564, C0003565, C0003566, C0003567, C0003568, C0003569, C0003570, C0003571
Primary DI / UDI-DI
16095672035659
Basic UDI-DI
697583867ALWSCI12BTVVN
Unit of Use DI
06095672035652
EMDN Code
W0503010101 Samples analyses, glass tubes
Device Class
Class A
Market of Registration
France

Manufacturer details

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

Other devices from Zhejiang ALWSCI Technologies Co., Ltd.

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Properties

  • Professional Testing

Other properties (10)

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