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480 device results listed.

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00858092006000

QBC STAR

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Drucker Diagnostics
Manufacturer SRN: US-MF-000031517
UDI-DI: 00858092006000
Basic UDI-DI: B-00858092006000
Reference: 429001
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:34

Manufacturer products Authorised representative products Authorised representative actors View details

LordsMed 5-Part Auto Hematology Analyzer

LM002

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470013
Basic UDI-DI: 890619447LM002EZ
Reference: LM002
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

ADAM-rWBC HT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540993
Basic UDI-DI: 880931754rWBCHT74
Reference: ADAM-rWBC HT
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMII

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540627
Basic UDI-DI: 880931754ADAMIIFC
Reference: ADAMII
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:55

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ADAM-rWBC

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540252
Basic UDI-DI: 880931754ADAMJC
Reference: ADAM-rWBC
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:55

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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

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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

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

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

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

Automatic Hematology Analyzer

DX-60P

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genegeo Diagnostics (Jiangsu) Co., Ltd.
Manufacturer SRN: CN-MF-000052709
UDI-DI: 06976154090560
Basic UDI-DI: 697615409DX-60PH6
Reference: 200108000003
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Türkiye
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

DX-60i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genegeo Diagnostics (Jiangsu) Co., Ltd.
Manufacturer SRN: CN-MF-000052709
UDI-DI: 06976154090553
Basic UDI-DI: 697615409DX-60iJE
Reference: 200108000002
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Türkiye
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

DX-60

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genegeo Diagnostics (Jiangsu) Co., Ltd.
Manufacturer SRN: CN-MF-000052709
UDI-DI: 06976154090546
Basic UDI-DI: 697615409DX-60FU
Reference: 200108000001
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Türkiye
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details