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716 device results listed.

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CBChroma™

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010587
Basic UDI-DI: 880613301058C9
Reference: FPRR060
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

PC100

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

Manufacturer: Dutch Medical Devices BV
Manufacturer SRN: NL-MF-000011504
UDI-DI: 08720299985506
Basic UDI-DI: 87202999855PC1009J
Reference: PC100
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:53

Manufacturer products View details

H7100

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156325271
Basic UDI-DI: 8592156H7IN0301PL
Reference: INS00087
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:25

Manufacturer products View details

H560

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156140416
Basic UDI-DI: 8592156HEIN0305WR
Reference: INS00078
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:25

Manufacturer products View details

ELite 580

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156113212
Basic UDI-DI: 8592156HEIN0303WM
Reference: INS00071
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:25

Manufacturer products View details

H360

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156107426
Basic UDI-DI: 8592156HEIN0304WP
Reference: INS00077
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:25

Manufacturer products View details

Mythic 18-22 FLUSH - CLEANER

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Orphée SA
Manufacturer SRN: CH-MF-000050926
UDI-DI: 07640142480068
Basic UDI-DI: 764014248HM18-0112N
Reference: HM18-011-025
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Poland
Authorised representative: PZ CORMAY Spółka Akcyjna
Last updated: 03.07.2026 06:31

Manufacturer products Authorised representative products Authorised representative actors View details

Medonic M-series M32 B

Medonic M-series M32

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796153
Basic UDI-DI: 735004079A001Y6
Reference: 1420021
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

Swelab Alfa Plus Basic

Swelab Alfa Plus

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040791172
Basic UDI-DI: 735004079A002Y8
Reference: 1420041
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

06979822870228

Cell Recognizer

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Cellomics (Shenzhen) Limited
Manufacturer SRN: CN-MF-000028334
UDI-DI: 06979822870228
Basic UDI-DI: 697982287CVCP0001H5
Reference: CVCP0001
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

06978741670100

BC-96SA BC-98SA BC-99SA

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen YC Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000048035
UDI-DI: 06978741670100
Basic UDI-DI: 697874167SABA001XL
Reference: BC-96SA
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.07.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

HEMA Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780135
Basic UDI-DI: 697850778HEM10QH
Reference: IN0123
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Auto 5-Part Hematology Analyzer

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698403885
Basic UDI-DI: 697769840GKPD0826T
Reference: GKPD082
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Auto 3-PartHematology Analyzer

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698403007
Basic UDI-DI: 697769840GKPD0816R
Reference: GKPD081
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

WHY6180，WHY6280，WHY6380，WHY6380S，WHY6580，HA-5000，HA-5500，HA-6000，HA-7006，HA-7003，HA-7004

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Poweam Medical Co., Ltd
Manufacturer SRN: CN-MF-000040207
UDI-DI: 06977226450008
Basic UDI-DI: 697722645BTHA01MF
Reference: WHY6180
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

iMC Ge52e

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

Manufacturer: Changsha Han Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000042919
UDI-DI: 06977216100418
Basic UDI-DI: 697721610020010002DR
Reference: 041
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter DxH Cell Lyse

IVD Class ANot specifiedOn the marketReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233709
Basic UDI-DI: 150995901HEMLYSEQK
Reference: 628019
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Cleaner

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233747
Basic UDI-DI: 150995901HEMCLEANERXZ
Reference: 628023
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

06976894951022

LA001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Essenlix Biotechnology (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000038839
UDI-DI: 06976894951022
Basic UDI-DI: 697689495LA001RW
Reference: LA001001
EMDN: W0202010202
EMDN description: SEMI-AUTOMATED HEMATOLOGY ANALYSERS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

Fully automated sample processing system

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changchun Sunostik Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000051464
UDI-DI: 06976704971028
Basic UDI-DI: 697670497102PC
Reference: DTS 800
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details