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Lysun

by Hangzhou Lysun Biotechnology Co., Ltd EUDAMED

Active European Union

Ref MOP-U21(25PCS), AMP-U11(25PCS), EGS-101(50PCS), BGM-102, RPS/15/2024, EGS-101(25PCS), PPX-U11（25PCS）, COV-201（1PCS）, FOB-U21(25PCS), TYP-P21, DEG-W21（25PCS）, SYP-W21（25PCS）, COT-U21(25PCS), PCP-U11（25PCS）, LH-U11(25PCS), DIM-F21(25PCS), EUS-101(2x25PCS), KET-U21(25PCS), MQL-U11(25PCS), BUP-U21(25PCS), BGM-101, FSH-U21(25PCS), BAR-U21（25PCS）, GULP-102, FCRAH-S26（1PCS）, TCA-U11（25PCS）, BGM-103, HLS-101(25PCS), CRP-W21-1(25PCS), MAL-W21- FV（25PCS）, TGS-101(25PCS), FCRAHP-S27, GUKC-102Model EGS-101（50PCS）, DOAD-U112, EGS-101（25PCS）, FOB-F21(25PCS), TYP-P21（25PCS）, DEG-P21（25PCS）, COT-U21（25PCS）, DIM-W21（25PCS）, EUS-101（2x25PCS）, BUP-U21(25PCS）, HLS-101（25PCS）, TGS-101（25PCS）, FCRAHP-S27(25PCS), GUKC-101

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-69717712015118K Basic UDI-DIDate22 Apr 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-69717712015118K Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Morphine (MOP) Rapid Test (Urine)
Amphetamine (AMP) Rapid Test (Urine)
Blood Glucose Test Strip
Blood Glucose Meter
One Step Multi-Drug Rapid Test(Urine)
Propoxyphene(PPX) Rapid Test Device(Urine)
COVID-19 Antigen Rapid Test Device(Colloidal Gold)
Fecal Occult Blood (FOB) Rapid Test
Typhoid Rapid Test
Dengue Rapid test
Syphilis Rapid test
Cotinine (COT) Rapid Test (Urine)
Phencyclidine(PCP) Rapid Test Device(Urine)
Luteinizing hormone Rapid test
D-dimer Rapid Test
Uric Acid Test Strip
Ketamine (KET) Rapid Test (Urine)
Methaqualone (MQL) Rapid Test Device (Urine)
Buprenorphine (BUP) Rapid Test (Urine)
Follicle-Stimulating Hormone Rapid test
Barbiturate (BAR) Rapid Test (Urine)
Multi-function Analyzer
Influenza A+B/ COVID-19/ RSV/ADV/HMPV Antigen Rapid Test
Tricyclic Antidepressants (TCA) Rapid Test Device(Urine)
High Density Lipoprotein Cholesterol Test Strip
C-Reactive Protein Semi Quantitative Rapid Test Device
Malaria Rapid Test
Triglycerides Test Strip
Influenza A+B/ COVID-19/ RSV/ADV/HMPV/HPIV Antigen Rapid Test
Multi-function Analyzer(Blood Glucose, Uric Acid, Blood Ketone, Total Cholesterol)
Model / Reference
MOP-U21(25PCS), AMP-U11(25PCS), EGS-101（50PCS）, EGS-101(50PCS), BGM-102, DOAD-U112, RPS/15/2024, EGS-101（25PCS）, EGS-101(25PCS), PPX-U11（25PCS）, COV-201（1PCS）, FOB-F21(25PCS), FOB-U21(25PCS), TYP-P21（25PCS）, TYP-P21, DEG-P21（25PCS）, DEG-W21（25PCS）, SYP-W21（25PCS）, COT-U21（25PCS）, COT-U21(25PCS), PCP-U11（25PCS）, LH-U11(25PCS), DIM-W21（25PCS）, DIM-F21(25PCS), EUS-101（2x25PCS）, EUS-101(2x25PCS), KET-U21(25PCS), MQL-U11(25PCS), BUP-U21(25PCS）, BUP-U21(25PCS), BGM-101, FSH-U21(25PCS), BAR-U21（25PCS）, GULP-102, FCRAH-S26（1PCS）, TCA-U11（25PCS）, BGM-103, HLS-101（25PCS）, HLS-101(25PCS), CRP-W21-1(25PCS), MAL-W21- FV（25PCS）, TGS-101（25PCS）, TGS-101(25PCS), FCRAHP-S27(25PCS), FCRAHP-S27, GUKC-102, GUKC-101
Primary DI / UDI-DI
D-69717712015118K, D-69717712014368W, D-69717712020518D, D-6971771209340A8, 6971771202235, D-69717712020688W, D-697177120136896, D-69717712023899M, D-697177120111587, D-697177120094199, D-69717712009349C, D-69717712009279F, D-69717712016969S, D-69717712013518M, D-69717712010858P, D-697177120101684, D-69717712021748W, D-69717712015979P, D-69717712016589J, D-69717712015048N, D-69717712093029Y, D-69717712010928L, D-69717712014508Q, 6971771202181, D-69717712025949Q, D-697177120137593, D-69717712004608L, D-69717712018499T, D-69717712010237Z, D-69717712009038Z, D-697177120174094, D-69717712042779P, 6971771203058, 6971771203065
Basic UDI-DI
B-69717712015118K, B-69717712014368W, B-69717712020518D, B-6971771209340A8, B-6971771202235, B-69717712020688W, B-697177120136896, B-69717712023899M, B-697177120111587, B-697177120094199, B-69717712009349C, B-69717712009279F, B-69717712016969S, B-69717712013518M, B-69717712010858P, B-697177120101684, B-69717712021748W, B-69717712015979P, B-69717712016589J, B-69717712015048N, B-69717712093029Y, B-69717712010928L, B-69717712014508Q, 697177120GULP102T7, B-69717712025949Q, B-697177120137593, B-69717712004608L, B-69717712018499T, B-69717712010237Z, B-69717712009038Z, B-697177120174094, B-69717712042779P, 697177120GUKC102PZ, 697177120GUKC101PX
EMDN Code
W0102090112, W0102160501, W0101060101, W02020680, W0102152209, W0102090115, W02010299, W0102160203, W0105011003, W0105099007, W0105090105, W0102090108, W0102160509, W0102050105, W0103020503, W0101060106, W0102160599, W0102090111, W0102050104, W0102160503, W0201069092, W0102160510, W0101060103, W0103020607, W0105090401, W0101060105, W0105099004, W0201069099
Device Class
Class IVD General
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000010254
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties

  • Reagent YesEUDAMEDNoEUDAMED
  • Professional Testing
  • Companion Diagnostics NoEUDAMEDYesEUDAMED
  • Surgical Instrument NoEUDAMEDYesEUDAMED
  • New Device NoEUDAMEDYesEUDAMED

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No