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DxC 500 AU Module, DxC 500i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590818234
Basic UDI-DI: 150995909DxC500iW5
Reference: C63521
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 00:51

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DxC 500 AU Module w/ ISE, DxC 500i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590818241
Basic UDI-DI: 150995909DxC500iW5
Reference: C63522
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 00:50

Manufacturer products Authorised representative products Authorised representative actors View details

S280

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: 06977290939065
Basic UDI-DI: 697729093MC03-2GQ
Reference: MC03A
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 00:46

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S290

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: 06977290939072
Basic UDI-DI: 697729093MC03-2GQ
Reference: MC03B
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 00:46

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06941967242444

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242444
Basic UDI-DI: 6973262860031423
Reference: 1302614
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.09.2026 00:46

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06941967242451

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242451
Basic UDI-DI: 6973262860031423
Reference: 1302615
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.09.2026 00:46

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06941967228790

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967228790
Basic UDI-DI: 69732628600141ZR
Reference: 0601003
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 22.09.2026 00:46

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Optic Cuvette

1000PCS/Box

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454248
Basic UDI-DI: 6970493090803003PF
Reference: 20.99.0052A
EMDN: W0202020185
EMDN description: COAGULOMETERS - CONSUMABLES
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 22.09.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

S96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: 06977290939089
Basic UDI-DI: 697729093MC06P4
Reference: MC061
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 00:43

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Automatic Hematology Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changchun Chenyu Taikang Medical Laboratory Co., Ltd
Manufacturer SRN: CN-MF-000046653
UDI-DI: 06977367850095
Basic UDI-DI: 697736785050101000283
Reference: TB-3100
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 22.09.2026 00:43

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S98

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: 06977290939096
Basic UDI-DI: 697729093MC06P4
Reference: MC062
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

S99

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: 06977290939102
Basic UDI-DI: 697729093MC06P4
Reference: MC063
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changchun Chenyu Taikang Medical Laboratory Co., Ltd
Manufacturer SRN: CN-MF-000046653
UDI-DI: 06977367850088
Basic UDI-DI: 69773678505010200028E
Reference: TB-5300
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 22.09.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

S100pro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: 06977290939010
Basic UDI-DI: 697729093MC08P8
Reference: MC081
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changchun Chenyu Taikang Medical Laboratory Co., Ltd
Manufacturer SRN: CN-MF-000046653
UDI-DI: 06977367850071
Basic UDI-DI: 69773678505010200028E
Reference: TB-5200
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 22.09.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changchun Chenyu Taikang Medical Laboratory Co., Ltd
Manufacturer SRN: CN-MF-000046653
UDI-DI: 06977367850064
Basic UDI-DI: 69773678505010200028E
Reference: TB-5100
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 22.09.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Aiforia® Prostate Cancer G4 Cribriform

IVD Class CIVDR 2017/746No longer on the marketDirect markingProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612083
Basic UDI-DI: 06429810612PR002Q4
Reference: Aiforia® Prostate Cancer G4 Cribriform
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 22.09.2026 00:41

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mariPOC® SARS-2 control samples

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingSingle use

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1204SCQQ
Basic UDI-DI: B-1204SCQQ
Reference: 1204SC
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 22.09.2026 00:37

Manufacturer products View details

Aiforia® Prostate Cancer PNI

IVD Class CIVDR 2017/746No longer on the marketDirect markingProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612106
Basic UDI-DI: 06429810612PR004Q8
Reference: Aiforia® Prostate Cancer PNI
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 22.09.2026 00:37

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TST 44.200 C

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: MEDITE Medical GmbH
Manufacturer SRN: DE-MF-000024626
UDI-DI: 04250530801400
Basic UDI-DI: 42505308MEDITESTAINHQ
Reference: 04-4740-03
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 00:37

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