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Breath Sampling Vial

by Zhejiang ALWSCI Technologies Co., Ltd. 101 variants

Ref C0003566Model C0003346, C0003186, C0003507, C0002598, C0003560, C0003561, C0003562, C0003563, C0003564, C0003565, C0003566, C0003567, C0003568, C0003569, C0003570, C0003571

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697583867ALWSCI12BTVVN Basic UDI-DI 16095672035666UDI-DIDate29 May 2025RegisteredStatusActive

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  • Withdrawn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

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
16095672035666
Basic UDI-DI
697583867ALWSCI12BTVVN
Unit of Use DI
06095672035669
EMDN Code
W0503010101 Samples analyses, glass tubes
Device Class
Class A
EU market of registration
France

Manufacturer details

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

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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