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ClinRep®

by RECIPE Chemicals + Instruments GmbH EUDAMED

Active European Union

Ref 10000, 4500, 35100, 14100, 31000, 3000, 2000, 23000, 14000, 1000, 22000, 21100, 6000, 22100, 4000, 25000, 21000, 27000, 35000

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-10000DR Basic UDI-DIDate25 Apr 2024RegisteredStatusActive

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  • Withdrawn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

Trade Name
ClinRep®
ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum ON-LINE
Device Name
ClinRep® Complete Kit for Aromatic Amino Acids in Plasma
ClinRep® Complete Kit for Metanephrines in Urine, advanced
ClinRep® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum by UHPLC
ClinRep® Complete Kit for Antiepileptics in Serum / Plasma by UHPLC
ClinRep® Complete Kit for Coenzyme Q10 in Plasma / Serum
ClinRep® Complete Kit for VMA, HVA, 5-HIAA in Urine
ClinRep® Complete Kit for Catecholamines in Urine
ClinRep® Complete Kit for Homocysteine in Plasma
ClinRep® Complete Kit, advanced,for Antiepileptics in Serum / Plasma
ClinRep® Complete Kit for Catecholamines in Plasma
ClinRep® Complete Kit for Vitamin A and E in Serum / Plasma
ClinRep® Complete Kit for Serotonin in Plasma
Carbohydrate-deficient Transferrin
ClinRep® Complete Kit for Vitamin A and E in Serum / Plasma by UHPLC
ClinRep® Complete Kit for Metanephrines in Urine
ClinRep® Complete Kit for Vitamin B2 in Whole Blood
ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum
ClinRep® Chromatography Kit for Vitamin B1, B2, B6
ClinRep® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum
Model / Reference
10000, 4500, 35100, 14100, 31000, 3000, 2000, 23000, 14000, 1000, 22000, 21100, 6000, 22100, 4000, 25000, 21000, 27000, 35000
Primary DI / UDI-DI
D-10000DR, D-4500AL, D-35100FP, D-14100ES, D-31000EN, D-30009L, D-2000BAMICX, D-23000ER, D-14000EM, D-1000BAMICC, D-22000EJ, D-21100EG, D-6000A9, 04049195211002, D-22100EP, D-40009T, D-25000F7, D-21000EB, D-27000FM, D-35000FJ
Basic UDI-DI
B-10000DR, B-4500AL, B-35100FP, B-14100ES, B-31000EN, B-30009L, B-2000BAMICX, B-23000ER, B-14000EM, B-1000BAMICC, B-22000EJ, B-21100EG, B-6000A9, 4049195B21X00AV, B-22100EP, B-40009T, B-25000F7, B-21000EB, B-27000FM, B-35000FJ
Direct Marketing DI
04049195211002
EMDN Code
W01010499, W0102060699, W0102070206, W0102080299, W01019099, W0102060601, W01021307, W0102070399, W0102120102, W0102039011, W0102070202
Device Class
Class IVD General
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000032553

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No