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75 device results listed.

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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

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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

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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

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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

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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

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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

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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

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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

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Metis 6000 Modular System (Integrated Clinical Chemistry and Immunochemistry)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414795578
Basic UDI-DI: 695441479557KZ
Reference: /
EMDN: W0201030102
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - MODERATE ROUTINE (Throughput > 800 and <= 2000 test/h)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:50

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Atellica CI Analyzer

IVDR_67_TTN_DUB-C_A_INST_Atellica CI 1900 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414229553
Basic UDI-DI: 0405686902224V9
Reference: 10947347
EMDN: W0201030102
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - MODERATE ROUTINE (Throughput > 800 and <= 2000 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

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COR

BD COR™ MX Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904439897
Basic UDI-DI: 038290PAODHOBV77
Reference: 443989
EMDN: W0201030182
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:44

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G322HCATE300MQ

HCA-TE-300

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnostics

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: G322HCATE300MQ
Basic UDI-DI: ++G322HCATE300MQ
Reference: NA
EMDN: W02010399
EMDN description: INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:36

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AUTOANALYZER MOD. MIURA ONE (15 Smp Pos) p/n 10750-02-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: 08033803510423
Basic UDI-DI: 803380351BCAAMIURAONE014X
Reference: I3310001209
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 23:08

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SPOTCHEM D-03 (SD-4820)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-17703GK
Basic UDI-DI: B-17703GK
Reference: 17703
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 10:17

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SPOTCHEM D-02 (SD-4810)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-17603GE
Basic UDI-DI: B-17603GE
Reference: 17603
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 10:17

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SPOTCHEM D-01 (SD-3810)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-17503G9
Basic UDI-DI: B-17503G9
Reference: 17503
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 10:17

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