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TintoStainer Plus Mini Automated System

BSB-7400-10

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dartmon Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000019183
UDI-DI: 06927210914665
Basic UDI-DI: 697550352BSB7400MINI2G
Reference: BSB-7400-10
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

Motic

Panthera E2 Panthera C2 Panthera DL Panthera Cloud PA43 PA53 BIO BA210E BA210LED BA310E BA310LED BA410E 50W BA410E 100W

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Motic China Group Co., Ltd.
Manufacturer SRN: CN-MF-000033671
UDI-DI: 06973967160657
Basic UDI-DI: 697396716Microscope001BG
Reference: BA310E
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 22:16

Manufacturer products Authorised representative products Authorised representative actors View details

06921807600306

CFMS LEPU-8800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600306
Basic UDI-DI: 692180760033EN
Reference: CFMS LEPU-8800
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 04.08.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Coagulation Analyzer

CX-2000

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053120036
Basic UDI-DI: 69449040AB32000032C
Reference: CX-2000
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:02

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Auto Coagulation Analyzer

CX-3000

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053120012
Basic UDI-DI: 69449040AB32000042E
Reference: CX-3000
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

Abacus 5 Hematology Analyzer with SSM

Hematology analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999883586280
Basic UDI-DI: 5999883586A5XW
Reference: A5SSM-1
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 04.08.2026 21:58

Manufacturer products View details

Coag 4D coagulometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000172
Basic UDI-DI: 599279504WP
Reference: g-Coag4Dm
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Hungary
Authorised representative: -
Last updated: 04.08.2026 21:57

Manufacturer products View details

ADVIA 560 Hematology System

IVDR_67_TTN_DUB-C_B_INST_Hematology System

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414601816
Basic UDI-DI: 0405686901597WC
Reference: 11170842
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

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D-W0202010185

Hemaray 55CRP

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-W0202010185
Basic UDI-DI: B-W0202010185
Reference: Hemaray 55CRP
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

miLab™ Cartridge CER

CCEA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Noul Co., Ltd.
Manufacturer SRN: KR-MF-000033621
UDI-DI: 18800100110215
Basic UDI-DI: B-18800100110215
Reference: CCEA
EMDN: W02020502
EMDN description: CERVICAL SCREENING SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 19:16

Manufacturer products Authorised representative products Authorised representative actors View details

miLab™ Cartridge BCM

CBCA

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Noul Co., Ltd.
Manufacturer SRN: KR-MF-000033621
UDI-DI: 18800100110116
Basic UDI-DI: B-18800100110116
Reference: CBCA
EMDN: W0202010192
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 19:16

Manufacturer products Authorised representative products Authorised representative actors View details

Printer Ribbon & Labels Cxi (1 Pack)

IVD Class ANot specifiedOn the market

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005634
Basic UDI-DI: 9349458001D9
Reference: S21.4604
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: CEpartner4U
Last updated: 04.08.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

microINR kit

KTB0001PL