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12ml Exetainer® Breath Vials

by Labco Limited United Kingdom EUDAMED

Ref 438G EMDN W0503010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506095015EXB001YL Basic UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Device Name
12ml Exetainer® Breath Vials
Model / Reference
438G
Primary DI / UDI-DI
05060950150045
Basic UDI-DI
506095015EXB001YL
EMDN Code
W0503010101 Samples analyses, glass tubes
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
GB-MF-000025515
Authorised representative
Advena Limited MT-AR-000000234

From the manufacturer

Manufacturer's product page: 12 ml Exetainer® Breath Vials

Other devices from Labco Limited

See all devices from Labco Limited →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 2823d4ad-be91-4094-9bac-3df172c8113d 61 fields · synced 25 Oct 2026