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83 device results listed.

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Integrated System

CSM-8000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202256653
Basic UDI-DI: B-06942202256653
Reference: CSM-8000
EMDN: W0201030103
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Integrated System

CSM-8000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202256646
Basic UDI-DI: B-06942202256646
Reference: CSM-8000
EMDN: W0201030103
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Integrated System

CSM-8000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202256622
Basic UDI-DI: B-06942202256622
Reference: CSM-8000
EMDN: W0201030103
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Integrated System

CSM-8000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202256615
Basic UDI-DI: B-06942202256615
Reference: 3012562
EMDN: W0201030103
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Integrated System

CSM-8000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202256639
Basic UDI-DI: B-06942202256639
Reference: CSM-8000
EMDN: W0201030103
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

1 biochemistry module + 1 immunoassay module + 1 sample unit +1ISE module+ 1 detergent proportioning module + 1 computer & cart

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577115
Basic UDI-DI: B-06925794577115
Reference: 1 biochemistry module + 1 immunoassay module + 1 sample unit +1ISE module+ 1 detergent proportioning module etc
EMDN: W0201030103
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:41

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Integrated System

CSM-9000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577108
Basic UDI-DI: B-06925794577108
Reference: CSM-9000
EMDN: W0201030103
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:41

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09120122922200

RAPTOR SERVER Analysis Software

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122922200
Basic UDI-DI: 91201229222JW
Reference: 22-0000-01
EMDN: W0201030192
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Safety summary (SSCP/SSP): TD-173_RAPTOR SERVER - Summary of Safety and Performance (SSP)_v1.0 · Rev. v1.0
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products Open in EUDAMED View details

Specific Protein Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904091570
Basic UDI-DI: 69449040XQYQ-3208CRP1**KN
Reference: CRP-M100
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:00

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SPOTCHEM D-00 QR (SD-9811)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034605
Basic UDI-DI: 4987486BC0107507GW
Reference: 107507
EMDN: W0201030180
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

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SPOTCHEM D-03 (SD-4820)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034582
Basic UDI-DI: 4987486BC0107505GS
Reference: 107505
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

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SPOTCHEM D-02 (SD-4810)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034575
Basic UDI-DI: 4987486BC0107504GQ
Reference: 107504
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

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SPOTCHEM D-01 (SD-3810)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034568
Basic UDI-DI: 4987486BC0107503GN
Reference: 107503
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S Fast Screen PLUS

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157630550
Basic UDI-DI: 426015763107BFSPSaMD0XXRR
Reference: 107853
EMDN: W0201030192
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

Manufacturer products View details

P-score Web Service (PWS)

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Prostatype Genomics AB
Manufacturer SRN: SE-MF-000013349
UDI-DI: 07350086460049
Basic UDI-DI: 735008646PG000424
Reference: PG0004
EMDN: W0201030192
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: -
Last updated: 23.07.2026 23:00

Manufacturer products View details

AUTOANALYZER MOD. MIURA ONE (9 Smp Pos) p/n 10750-00-A

AUTOANALYZER MOD. MIURA ONE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510409
Basic UDI-DI: 803380351BCAAMIURAONE014X
Reference: I3310001210
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

AUTOANALYZER MOD. MIURA DA (79 Smp Pos) p/n 10001-01-A

AUTOANALYZER MOD. MIURA DA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510362
Basic UDI-DI: 803380351BCAAMIURADA001T4
Reference: I3260011206
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

AUTOANALYZER MOD. MIURA 200 SA (31 Rgt Pos) p/n 11025-00-A

AUTOANALYZER MOD. MIURA 200 SA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510249
Basic UDI-DI: 803380351BCAAM200SA000173
Reference: I3320001201-E
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

AUTOANALYZER MOD. MIURA 200 DA (31 Rgt Pos) p/n 10997-00-A

AUTOANALYZER MOD. MIURA 200 DA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510201
Basic UDI-DI: 803380351BCAAM200DA0001YV
Reference: I3320001221
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

AUTOANALYZER MOD. HEMO ONE p/n 11154-10-A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510195
Basic UDI-DI: 803380351BCAAHEMOONE001PC
Reference: I3330000001
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details