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Urinalysis Strips

by Healgen Scientific Limited Liability Company 3 variants

Ref URS-4T, URS-6T, URS-5T, URS-11T, URS-3T, URS-9T, URS-2T, URS-7T, URS-14T, URS-13T, URS-XXTModel URS-1T

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDD NumberB-URS-4THGX3 Basic UDI-DI Date30 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
URS-4T, URS-6T, URS-5T, URS-11T, URS-3T, URS-9T, URS-1T, URS-2T, URS-7T, URS-14T, URS-13T, URS-XXT
Primary DI / UDI-DI
D-URS-4THGX3, D-URS-6THGXH, D-URS-5THGXA, D-URS-11THGJT, D-URS-3THGWU, D-URS-9THGY6, D-URS-1THGWE, D-URS-7THGXQ, D-URS-14THGKG, D-URS-13THGK9, D-URS-XXTHG8A, D-URS-2THGWM
Basic UDI-DI
B-URS-4THGX3, B-URS-6THGXH, B-URS-5THGXA, B-URS-11THGJT, B-URS-3THGWU, B-URS-9THGY6, B-URS-1THGWE, B-URS-7THGXQ, B-URS-14THGKG, B-URS-13THGK9, B-URS-XXTHG8A, B-URS-2THGWM
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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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