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209 device results listed.

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CA15-3 Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334817918
Basic UDI-DI: B-06950334817918
Reference: 52026235
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334817895
Basic UDI-DI: B-06950334817895
Reference: 52026129
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334816263
Basic UDI-DI: 69503348GEA004D4
Reference: 42005007
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Electrolyte Reagent

GE-1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334816256
Basic UDI-DI: B-06950334816256
Reference: 42047001
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 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334815914
Basic UDI-DI: B-06950334815914
Reference: 52026208
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Total Immunoglobulin E (Total IgE) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334815891
Basic UDI-DI: B-06950334815891
Reference: 52026210
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone (Testo) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334815105
Basic UDI-DI: B-06950334815105
Reference: 52026115
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone (Prog) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334815082
Basic UDI-DI: B-06950334815082
Reference: 52026114
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Interleukin 6 (IL-6) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334815075
Basic UDI-DI: B-06950334815075
Reference: 52105076
EMDN: W01030608
EMDN description: CYTOKINES CALIBRATORS/CONTROLS
First on market country: Belgium
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH Vitamin D (25-OH Vit-D) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334815044
Basic UDI-DI: B-06950334815044
Reference: 52105085
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin (HbA1c) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334814986
Basic UDI-DI: B-06950334814986
Reference: 52105024
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN 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

KT05LH 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: 06950334814962
Basic UDI-DI: 69503348KTA009L7
Reference: 23013009
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

KT05 DIFF 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: 06950334814955
Basic UDI-DI: 69503348KTA007L3
Reference: 23019008
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

06950334814443

Concentrated Cleaning Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334814443
Basic UDI-DI: 69503348PAA004FD
Reference: 32019080
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Probe Cleaning Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334814436
Basic UDI-DI: 69503348PAA003FB
Reference: 32107002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen (CEA) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334813835
Basic UDI-DI: B-06950334813835
Reference: 52026123
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Free Thyroxine (FT4) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334813828
Basic UDI-DI: B-06950334813828
Reference: 52026121
EMDN: W01020402
EMDN description: FREE THYROXINE
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

Free Triiodothyronine (FT3) Test Kit (Immunofluorescence)

52026120

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334813811
Basic UDI-DI: B-06950334813811
Reference: 52026120
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
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

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