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203 device results listed.

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Alpha Fetoprotein (AFP) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334813798
Basic UDI-DI: B-06950334813798
Reference: 52026122
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334813781
Basic UDI-DI: B-06950334813781
Reference: 52026117
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Interleukin 6 (IL-6) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334813774
Basic UDI-DI: B-06950334813774
Reference: 52026108
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaning solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334813231
Basic UDI-DI: 69503348GEA002CY
Reference: 42005005
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

KT05A LH Lyse

Please see UDI-DIs for details

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334813224
Basic UDI-DI: 69503348KTA009L7
Reference: 22013011
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Electrolyte Reagent

GE-2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334809524
Basic UDI-DI: B-06950334809524
Reference: 42048001
EMDN: W01010403
EMDN description: MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein (CRP) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334809487
Basic UDI-DI: B-06950334809487
Reference: 52026107
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334809470
Basic UDI-DI: B-06950334809470
Reference: 52026116
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

KT05A LD Lyse

KT05/KT05A LD Lyse

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334809135
Basic UDI-DI: 69503348KTA010KQ
Reference: 22020017
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

KT05A LD Lyse

KT05/KT05A LD Lyse

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334809128
Basic UDI-DI: 69503348KTA010KQ
Reference: 22019015
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

06950334809104

WP21A, WP21B, WP21E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334809104
Basic UDI-DI: 69503348WPA001P7
Reference: WP21A
EMDN: W0201010299
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

06950334809081

KT-8000

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334809081
Basic UDI-DI: B-06950334809081
Reference: KT-8000
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

β-Human Chorionic Gonadotropin (β-HCG) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808794
Basic UDI-DI: B-06950334808794
Reference: 52105021
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808756
Basic UDI-DI: B-06950334808756
Reference: 52108036
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808732
Basic UDI-DI: B-06950334808732
Reference: 52105055
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB (CK-MB) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808718
Basic UDI-DI: B-06950334808718
Reference: 52105061
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein (CRP) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808695
Basic UDI-DI: B-06950334808695
Reference: 52081005
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin (FER) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808664
Basic UDI-DI: B-06950334808664
Reference: 52026113
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

Prolactin (PRL) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808640
Basic UDI-DI: B-06950334808640
Reference: 52026076
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

06950334808626

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808626
Basic UDI-DI: B-06950334808626
Reference: 52026072
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details