Skip to content

Urinalysis Strips

by HEALSTONE Biotech Inc. EUDAMED

Active European Union

Ref URS-12T

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-URS-12THSKS Basic UDI-DIDate29 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  • Withdrawn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

Model / Reference
URS-12T
Primary DI / UDI-DI
D-URS-12THSKS
Basic UDI-DI
B-URS-12THSKS
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CA-MF-000057743
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healstone Biotech, Inc.

See all devices from Healstone Biotech, Inc. →

Properties

  • Professional Testing

Other properties (9)

  • 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