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295 device results listed.

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Automated Hematology Analyzer Lyse

MS-5LH

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595746303
Basic UDI-DI: 693659579013PG
Reference: XQ9013Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Diluent

MS-5DIL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595746297
Basic UDI-DI: 693659579014PJ
Reference: XQ9014Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291983440
Basic UDI-DI: B-06970291983440
Reference: ZK411CY
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

1×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291983433
Basic UDI-DI: B-06970291983433
Reference: ZK411BY
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Calibrator

5×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291983426
Basic UDI-DI: B-06970291983426
Reference: JZ411TY
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Lyse

LYC-1, LYC-2

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980883
Basic UDI-DI: 693659579008PP
Reference: XQ9008Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Cleanser

CLE-P

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980944
Basic UDI-DI: 693659579908R4
Reference: 9908Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Lyse

LYC-1, LYC-2

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980906
Basic UDI-DI: 693659579008PP
Reference: XQ9009Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Lyse

LYA-1, LYA-2, LYA-3

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980821
Basic UDI-DI: 693659579002PB
Reference: XQ9004Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Diluent

DIL-E

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980838
Basic UDI-DI: 693659579005PH
Reference: XQ9005Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Lyse

LYE-1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980869
Basic UDI-DI: 693659579007PM
Reference: XQ9007Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Diluent

DIL-C

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980845
Basic UDI-DI: 693659579006PK
Reference: XQ9006Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Lyse

LYA-1, LYA-2, LYA-3

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980814
Basic UDI-DI: 693659579002PB
Reference: XQ9003Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Lyse

LYA-1, LYA-2, LYA-3

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980807
Basic UDI-DI: 693659579002PB
Reference: XQ9002Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer Diluent

DIL-A

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291980791
Basic UDI-DI: 693659579001P9
Reference: XQ9001Y
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Catecholamine Kit(LC-MS/MS)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595780673
Basic UDI-DI: B-06936595780673
Reference: ZY3079P
EMDN: W0102090204
EMDN description: CATECHOLAMINES
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 18:59

Manufacturer products Authorised representative products Authorised representative actors View details

Bile Acids Kit(LC-MS/MS)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595780666
Basic UDI-DI: B-06936595780666
Reference: ZY3078P
EMDN: W01010202
EMDN description: BILE ACIDS
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 18:59

Manufacturer products Authorised representative products Authorised representative actors View details

Enhanced Wash Buffer

IVD Class ANot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595779615
Basic UDI-DI: 693659571007MV
Reference: CF1007Q
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 18:59

Manufacturer products Authorised representative products Authorised representative actors View details

Enhanced Wash Buffer

IVD Class ANot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595778144
Basic UDI-DI: 693659579914QX
Reference: BF9914P
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 18:59

Manufacturer products Authorised representative products Authorised representative actors View details

Electrolyte Multiple Quality Control (Direct Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595776805
Basic UDI-DI: B-06936595776805
Reference: BK0130P
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 18:59

Manufacturer products Authorised representative products Authorised representative actors View details