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03.08.2026 06:01

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638 device results listed.

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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

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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

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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

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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

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Blood Cell Counting Plate

PFD-1B 50 tests/kit

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

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377306477
Basic UDI-DI: 697049309W02020000003A6
Reference: PO-0031-01
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:27

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Semi-auto Chemistry Analyzer

DP-C16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377301335
Basic UDI-DI: 6970493090802003P8
Reference: DMP402DP-C19
EMDN: W0202010202
EMDN description: SEMI-AUTOMATED HEMATOLOGY ANALYSERS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

DF1-CRP

IVD Class BIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117452251
Basic UDI-DI: 6970493090608004PS
Reference: XQ-0004-04
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Calibrator

DM-CAL-PF

IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117451896
Basic UDI-DI: 6970493090608031PV
Reference: DE/CA20/00119499
EMDN: W0202010285
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

BC-7500[B] CRP、BC-7500[N] CRP、BC-7500[R] CRP、BC-7500[NR] CRP、BC-7300[B] CRP、BC-7300[N] CRP、BC-7300[R] CRP、BC-7300[NR] CRP、BC-7500[B] CS、BC-7500[N] CS、BC-7500[R] CS、BC-7500[NR] CS

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977092
Basic UDI-DI: 69449040AB3000011ZE
Reference: BC-7500[B] CRP
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

BC-6600Plus、BC-6700Plus、BC-6800Plus

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977054
Basic UDI-DI: 69449040AB3000020ZF
Reference: BC-6600Plus
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

BC-5310 CRP、BC-5100 CRP

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415976941
Basic UDI-DI: 69449040AB3000017ZS
Reference: BC-5100 CRP
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

BC-5390 CRP、BC-5180 CRP

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415970871
Basic UDI-DI: 69449040AB3000016ZQ
Reference: BC-5390 CRP
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

BH-5380CRP 5-Part-Diff Auto Hematology Analyzer

BH-5380CRP、BH-5160CRP、BH-5160CS

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740730464
Basic UDI-DI: 69357407IBH000003NB
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

BH-6180 5-Part-Diff Auto Hematology Analyzer

BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740730433
Basic UDI-DI: 69357407IBH000004ND
Reference: /
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

URIT-5160 5-Part-Diff Auto Hematology Analyzer

URIT-5160、BH-5100 、BH-5390

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740723053
Basic UDI-DI: 69357407IBH000002N9
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

URIT-3000Plus Automated Hematology Analyzer

URIT-3000Plus、URIT-3020

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740720359
Basic UDI-DI: 69357407IBH000005NF
Reference: /
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

BH-40P Automated Hematology Analyzer

BH-40P、BH-70P

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740718929
Basic UDI-DI: 69357407IBH000001N7
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:03

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Auto Hematology Analyzer

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377306156
Basic UDI-DI: 697049309W02023012007CS
Reference: XQ-0110-14
EMDN: W0202010101
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details