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716 device results listed.

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Automatic Hematology Analyzer

SMT-30 Pro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000033945
UDI-DI: 06975347780530
Basic UDI-DI: 6975347780530FE
Reference: AWGSFLFXY-00003
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

SMT-50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000033945
UDI-DI: 06975347780066
Basic UDI-DI: 6975347780066FA
Reference: AZZSMT50EN
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

SMT-30

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000033945
UDI-DI: 06975347780004
Basic UDI-DI: 6975347780004EL
Reference: AZZSMT30EN
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

06975200381287

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrument

Manufacturer: Shenzhen Xilaiheng Medical Electronics Co.,Ltd.
Manufacturer SRN: CN-MF-000047090
UDI-DI: 06975200381287
Basic UDI-DI: 697520038H30004E
Reference: /
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: HUMISS TRADING S. L.
Last updated: 02.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

06975200380105

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrument

Manufacturer: Shenzhen Xilaiheng Medical Electronics Co.,Ltd.
Manufacturer SRN: CN-MF-000047090
UDI-DI: 06975200380105
Basic UDI-DI: 697520038H50004U
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: HUMISS TRADING S. L.
Last updated: 02.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hematology Analyzer

MS-H630

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ningbo MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014369
UDI-DI: 06975096610935
Basic UDI-DI: 697509661MSH001Q8
Reference: /
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Türkiye
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 18:09

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5-Part Auto Hematology Analyzer

BH-HA610, BH-HA510, BH-HA630, BH-HA640, BH-HA650, etc.

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000025971
UDI-DI: 06974901972275
Basic UDI-DI: 69749019722AHA5***HE
Reference: BH-HA610
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:42

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Hematology Analyzer

BH-HA310

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000025971
UDI-DI: 06974901972206
Basic UDI-DI: 69749019722HA3***8Q
Reference: BH-HA310
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:42

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Multifunctional blood analyzer

HEA-5000S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674896938
Basic UDI-DI: 69746748900191A2
Reference: A060025
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:08

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06974442120012

MG-G0R-CA1-027, MG-G0R-GA1-027, MG-G0R-HA1-027

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Zhuji Zhiwei Information and Technology Ltd.
Manufacturer SRN: CN-MF-000015261
UDI-DI: 06974442120012
Basic UDI-DI: 697444212ZWXK.0001.27T3
Reference: GCA1027
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 16:08

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740257

Speedry WBC

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740257
Basic UDI-DI: 697331674WBC00000QR
Reference: A411011
EMDN: W0202010299
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

Z3 CRP

Z3CRP

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861457
Basic UDI-DI: 6973262863020101*******96
Reference: 3020101
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861402
Basic UDI-DI: 6973262863020104*******AX
Reference: 3020104
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

Z50

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967213123
Basic UDI-DI: 69732628630301*********ZR
Reference: 3030102
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967200932

EXZ 6000

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200932
Basic UDI-DI: 69732628600061ZS
Reference: 02-13-01-0004-00
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967200895

EXZ 6000Pro, EXZ 6010Pro, EXZ 6020Pro

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200895
Basic UDI-DI: 6973262860003924
Reference: 02-13-04-0010-00
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

Hemax320 Hemax330 Hemax330AL Hemax330P/C Hemax330Vet Hemax33 Hemax33P/C Hemax530AL Hemax530 Hemax530CT Hemax531 Hemax532 Hemax53 Hemax53CT Hemax53+Fi Hemax53+Cap Hemax53+Cap+Fi Hemax53+CT+Fi Hemax53+Cap+CT Hemax53+Cap+CT+Fi Hemax53AL+Fi

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337850037
Basic UDI-DI: 697233785HemaA0024Y
Reference: 80100 80120 80300 80310 80320 80330 80340 8035080200 80500 80301 80400 80600 80900 80910 80920 80930 80360 80370 80380
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

F 880; F 810; F 800

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168357538
Basic UDI-DI: 69721683520019R
Reference: EBL9207003
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Germany
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

F 560, F 580

IVD Class BIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168357460
Basic UDI-DI: 69721683522WV
Reference: EBL9201002
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Türkiye
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

F 680

IVD Class BIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168355176
Basic UDI-DI: 6972168352006A3
Reference: EBL9201022
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details