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bt products URI11F URINE STRIP

by Bi̇li̇msel Tibbi̇ Ürünler Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ EUDAMED

Active European Union

Ref URF-11100Model URF-11

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08697643494482 Basic UDI-DIDate24 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
URI11F Urine Strip
Model / Reference
URF-11, URF-11100
Primary DI / UDI-DI
08697643494482
Basic UDI-DI
B-08697643494482
EMDN Code
W01010901 Urine multi-constituent test strips / cassettes (automated)
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017223

Other devices from Bi̇li̇msel Tibbi̇ Ürünler Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Bi̇li̇msel Tibbi̇ Ürünler Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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