Skip to content

Vacusera

by Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.Ş. 217 variants

Ref 436828

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-M7124368281 Basic UDI-DI Date3 Nov 2023RegisteredStatusActive
European UnionCE/IVDD NumberB-M7124368281 Basic UDI-DI Date3 Nov 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
VACUSERA® 8 ml Chlorhexidine Urine Tube
VACUSERA® Urine Tubes
Model / Reference
436828
Primary DI / UDI-DI
M7124368281, +M7124368281J
Basic UDI-DI
B-M7124368281, ++M712235URINETUBEX3
Direct Marketing DI
+M7124368281J
EMDN Code
W05010202 Urine collection, tubes
Device Class
Class IVD General
Class A
EU 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

  • 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