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Vacusera

by Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.Ş. Türkiye EUDAMED

Ref 435816

EMDN W05010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-M7124358161 Basic UDI-DIDate3 Nov 2023RegisteredStatusActive
European UnionCE/IVDD NumberB-M7124358161 Basic UDI-DIDate3 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
VACUSERA® 6 ml Boric Acid Urine Tube
VACUSERA® Urine Tubes
Model / Reference
435816
Primary DI / UDI-DI
M7124358161, +M7124358161F
Basic UDI-DI
B-M7124358161, ++M712235URINETUBEX3
Direct Marketing DI
+M7124358161F
EMDN Code
W05010202 Urine collection, tubes
Device Class
Class IVD General
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000025066

Other devices from Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.Ş.

See all devices from Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.Ş. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 38fffdf2-cbb8-4d4b-9a6e-43dd2c48c1d4 61 fields · synced 24 Oct 2026
  • EUDAMED +M7124358161F|++M712235URINETUBEX3 61 fields · synced 24 Oct 2026