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Reagent strips for urinalysis

by Yercon Diagnostic Co., Ltd. 77 variants

Ref URS-11HⅡ (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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971007255349 Basic UDI-DI 06971007255349UDI-DIDate15 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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-11HⅡ (125 strips/bottle)
Primary DI / UDI-DI
06971007255349
Basic UDI-DI
B-06971007255349
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
Device Class
Class IVD devices for self-testing
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

  • 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