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Reagent strips for urinalysis

by Yercon Diagnostic Co., Ltd. 87 variants

Ref URS-H11II (125 strips/bottle)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971007255011 Basic UDI-DI 06971007255011UDI-DIDate22 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  • Withdrawn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

Device Name
Reagent strips for urinalysis
Model / Reference
URS-H11II (125 strips/bottle)
Primary DI / UDI-DI
06971007255011
Basic UDI-DI
B-06971007255011
EMDN Code
W0101060205 Urine multi-constituent test strips (automated)
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028380
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Yercon Diagnostic Co., Ltd.

See all devices from Yercon Diagnostic Co., Ltd. →

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