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Reagent strips for urinalysis

by Yercon Diagnostic Co., Ltd. EUDAMED

Active European Union

Ref URS-11FA (100 strips/bottle), URS-3ACC (2 strips/bag), URS-11U (1 strip/bag), URS-7S (25 strips/bottle), URS-5 (50 strips/bottle), URS-6 (1 strip/bag), URS-3S (150 strips/bottle), URS-Ketone (100 strips/bottle), URS-3S (1 strip/bag), URS-8SG (3 strips/bag), URS-6S (150 strips/bottle), URS-10M (50 strips/bottle), URS-11H (1 strip/bag), URS-A10 (1 strip/bag), URS-Glucose (100 strips/bottle), URS-A10 (3 strips/bag), URS-11U (2 strips/bag), URS-2 (50 strips/bottle), URS-2 (25 strips/bottle), URS-6S (125 strips/bottle), URS-5K (2 strips/bag), URS-7S (1 strip/bag), URS-10A (150 strips/bottle), URS-10A (2 strips/bag), URS-14H (1 strip/bag), URS-3 (3 strips/bag), URS-3 (100 strips/bottle), URS-11H (50 strips/bottle), URS-Glucose (125 strips/bottle), URS-6 (100 strips/bottle), URS-Ketone (50 strips/bottle), URS-Protein (3 strips/bag), URS-3ACC (3 strips/bag), URS-1S (50 strips/bottle), URS-FA10 (25 strips/bottle), URS-7 (2 strips/bag), URS-Protein (125 strips/bottle), URS-11U (30 strips/bottle), URS-8SG (25 strips/bottle), URS-2S (2 strips/bag), URS-5K (50 strips/bottle), URS-5 (150 strips/bottle), URS-7S (30 strips/bottle), URS-U10 (2 strips/bag), URS-Protein (100 strips/bottle), URS-8 (2 strips/bag), URS-FA10 (50 strips/bottle), URS-14H (3 strips/bag), URS-8 (25 strips/bottle), URS-4 (25 strips/bottle), URS-U10 (50 strips/bottle)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971007250290 Basic UDI-DIDate15 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  • Withdrawn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

Device Name
Reagent strips for urinalysis
Model / Reference
URS-11FA (100 strips/bottle), URS-3ACC (2 strips/bag), URS-11U (1 strip/bag), URS-7S (25 strips/bottle), URS-5 (50 strips/bottle), URS-6 (1 strip/bag), URS-3S (150 strips/bottle), URS-Ketone (100 strips/bottle), URS-3S (1 strip/bag), URS-8SG (3 strips/bag), URS-6S (150 strips/bottle), URS-10M (50 strips/bottle), URS-11H (1 strip/bag), URS-A10 (1 strip/bag), URS-Glucose (100 strips/bottle), URS-A10 (3 strips/bag), URS-11U (2 strips/bag), URS-2 (50 strips/bottle), URS-2 (25 strips/bottle), URS-6S (125 strips/bottle), URS-5K (2 strips/bag), URS-7S (1 strip/bag), URS-10A (150 strips/bottle), URS-10A (2 strips/bag), URS-14H (1 strip/bag), URS-3 (3 strips/bag), URS-3 (100 strips/bottle), URS-11H (50 strips/bottle), URS-Glucose (125 strips/bottle), URS-6 (100 strips/bottle), URS-Ketone (50 strips/bottle), URS-Protein (3 strips/bag), URS-3ACC (3 strips/bag), URS-1S (50 strips/bottle), URS-FA10 (25 strips/bottle), URS-7 (2 strips/bag), URS-Protein (125 strips/bottle), URS-11U (30 strips/bottle), URS-8SG (25 strips/bottle), URS-2S (2 strips/bag), URS-5K (50 strips/bottle), URS-5 (150 strips/bottle), URS-7S (30 strips/bottle), URS-U10 (2 strips/bag), URS-Protein (100 strips/bottle), URS-8 (2 strips/bag), URS-FA10 (50 strips/bottle), URS-14H (3 strips/bag), URS-8 (25 strips/bottle), URS-4 (25 strips/bottle), URS-U10 (50 strips/bottle)
Primary DI / UDI-DI
06971007250290, 06971007251655, 06971007251204, 06971007253062, 06971007254762, 06971007251327, 06971007255776, 06971007250481, 06971007250948, 06971007252386, 06971007255813, 06971007254700, 06971007250832, 06971007250849, 06971007250474, 06971007252225, 06971007251884, 06971007254731, 06971007253338, 06971007255134, 06971007251679, 06971007250993, 06971007256056, 06971007251921, 06971007250818, 06971007252652, 06971007250085, 06971007254304, 06971007255059, 06971007250702, 06971007254366, 06971007252294, 06971007252331, 06971007254397, 06971007252942, 06971007252010, 06971007255066, 06971007253970, 06971007253079, 06971007251631, 06971007254441, 06971007256124, 06971007253789, 06971007251556, 06971007250191, 06971007252027, 06971007254359, 06971007252195, 06971007253390, 06971007253352, 06971007254328
Basic UDI-DI
B-06971007250290, B-06971007251655, B-06971007251204, B-06971007253062, B-06971007254762, B-06971007251327, B-06971007255776, B-06971007250481, B-06971007250948, B-06971007252386, B-06971007255813, B-06971007254700, B-06971007250832, B-06971007250849, B-06971007250474, B-06971007252225, B-06971007251884, B-06971007254731, B-06971007253338, B-06971007255134, B-06971007251679, B-06971007250993, B-06971007256056, B-06971007251921, B-06971007250818, B-06971007252652, B-06971007250085, B-06971007254304, B-06971007255059, B-06971007250702, B-06971007254366, B-06971007252294, B-06971007252331, B-06971007254397, B-06971007252942, B-06971007252010, B-06971007255066, B-06971007253970, B-06971007253079, B-06971007251631, B-06971007254441, B-06971007256124, B-06971007253789, B-06971007251556, B-06971007250191, B-06971007252027, B-06971007254359, B-06971007252195, B-06971007253390, B-06971007253352, B-06971007254328
EMDN Code
W0101060204, W0101060205
Device Class
Class IVD devices for self-testing
Class IVD General
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 YesEUDAMEDNoEUDAMED
  • Near-Patient Testing YesEUDAMEDNoEUDAMED
  • Professional Testing NoEUDAMEDYesEUDAMED

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Companion Diagnostics: No
  • Surgical Instrument: No