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Reagent strips for urinalysis

by Yercon Diagnostic Co., Ltd. China EUDAMED

Ref URS-10FA (3 strips/bag) EMDN W0101060204

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971007252621 Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Reagent strips for urinalysis
Model / Reference
URS-10FA (3 strips/bag)
Primary DI / UDI-DI
06971007252621
Basic UDI-DI
B-06971007252621
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
Device Class
Class IVD devices for self-testing
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 & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Near-Patient Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 91b4480c-3045-402d-a5c0-a06317381c5d 61 fields · synced 24 Oct 2026