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Yumizen G200

1300036315

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008263
Basic UDI-DI: 361023ymz_g200XS
Reference: 1300036315
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen H2500

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008195
Basic UDI-DI: 361023ymz_h2500JX
Reference: 1300031326, 1300031327, 1300031328, 1300031329
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen H1500

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008188
Basic UDI-DI: 361023ymz_h1500JQ
Reference: 1300031324, 1300031325, 1300046881, 1300046884
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Pentra XLR

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006405
Basic UDI-DI: 361023pentra_xlrEA
Reference: 1280110003, 1280110005, 1280110007, 1280110009, 1280110011, 1280110013,1280110015, 1280110016, 1300039852, 1300039853
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

ABX Pentra XL80

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006399
Basic UDI-DI: 361023pentra_xl80LB
Reference: 1280110025, 1280110027, 1280110029,1280110031,1280110033, 1280110035, 1280110036, 1280110038, 1300039850, 1300039851
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Atellica HEMA 530

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009536
Basic UDI-DI: 361023at_530GF
Reference: 1300128174
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

Atellica HEMA 520 CT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009529
Basic UDI-DI: 361023at_520_ct5U
Reference: 1300128173
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

Atellica HEMA 520 OT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009512
Basic UDI-DI: 361023at_520_ot6Y
Reference: 1300128171
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ST Genesia®

Automatic Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450868142
Basic UDI-DI: 3607450INST0007UR
Reference: 86814
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

sthemO 201

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450590326
Basic UDI-DI: 3607450INST0001UD
Reference: 59032
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

sthemO 301

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450590180
Basic UDI-DI: 3607450INST0002UF
Reference: 59018
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

STart Max

Semi-automatic Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450590173
Basic UDI-DI: 3607450INST0006UP
Reference: 59017
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

STA R Max® 2

STA R Max

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450589924
Basic UDI-DI: 3607450INST0004UK
Reference: 58992
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

STA Compact Max® 2

STA Compact Max

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450589894
Basic UDI-DI: 3607450INST0003UH
Reference: 58989
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

STA Satellite Max®

STA Satellite Max

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450580303
Basic UDI-DI: 3607450INST0005UM
Reference: 58030
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

COULTER DxH Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233730
Basic UDI-DI: 150995901HEMCLEANERXZ
Reference: 628022
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Retic Pack

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233723
Basic UDI-DI: 150995901HEMRETICPACK4R
Reference: 628021
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Diff Pack

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233716
Basic UDI-DI: 150995901HEMDIFFPACKQJ
Reference: 628020
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Cell Lyse (1L)

Coulter DxH Cell Lyse

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233693
Basic UDI-DI: 150995901HEMLYSEQK
Reference: 628018
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter DxH Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233686
Basic UDI-DI: 150995901HEMDILUENT5R
Reference: 628017
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details