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231 device results listed.

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Human Micro-albuminuria (mALB) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819554
Basic UDI-DI: B-06950334819554
Reference: 32027194
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Heparin-binding protein (HBP) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819547
Basic UDI-DI: B-06950334819547
Reference: 32027176
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid Protein A (SAA) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819530
Basic UDI-DI: B-06950334819530
Reference: 32027202
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein (CRP) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819516
Basic UDI-DI: B-06950334819516
Reference: 32027196
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemiluminescence Analyzer

MT120S, MT120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825043
Basic UDI-DI: 69503348MTA008LX
Reference: MT120S
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Buffer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825036
Basic UDI-DI: 69503348MTA007LV
Reference: 60022001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tube Cleaning Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825029
Basic UDI-DI: 69503348MTA006LT
Reference: 62005002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Substrate Tube Cleaning Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825012
Basic UDI-DI: 69503348MTA005LR
Reference: 62014001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Substrate Solution

2 × 250 T/Kit, 2 × 100 T/Kit , 2 × 500 T/Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825005
Basic UDI-DI: 69503348MTA004LP
Reference: 62031001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Concentrated Wash Buffer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334824992
Basic UDI-DI: 69503348MTA003LM
Reference: 62020001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334802396
Basic UDI-DI: 69503348KT06RT
Reference: KT-42
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334802402
Basic UDI-DI: 69503348KT06RT
Reference: KT-40
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein (CRP) Detection Kit (Nephelometry)

25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-PA000455
Basic UDI-DI: B-PA000455
Reference: 32026009
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein (CRP)Detection Kit(Nephelometry)

2*25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-PA000353
Basic UDI-DI: B-PA000353
Reference: 32080009
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin (HbA1c) Detection Kit (Nephelometry)

25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-PA00024Z
Basic UDI-DI: B-PA00024Z
Reference: 32026008
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin (HbA1c) Detection Kit (Nephelometry)

2*25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-PA00014X
Basic UDI-DI: B-PA00014X
Reference: 32080008
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin (FER) Test Kit (Immunofluorescence)

50T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0026ZA
Basic UDI-DI: B-FA0026ZA
Reference: 52027107
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

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

50T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0025Z8
Basic UDI-DI: B-FA0025Z8
Reference: 52027112
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone (Testo) Test Kit (Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0024Z6
Basic UDI-DI: B-FA0024Z6
Reference: 52027110
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone (LH)Test Kit (Immunofluorescence)

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0021YY
Basic UDI-DI: B-FA0021YY
Reference: 52027076
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details