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113 device results listed.

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CLENZ Solution

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-664090QW
Basic UDI-DI: B-664090QW
Reference: 664090
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMII™-CD3/CD4/CD8 Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541020
Basic UDI-DI: B-08809317541020
Reference: CD348K-025
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

ADAM-rWBC Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541006
Basic UDI-DI: B-08809317541006
Reference: ADHK-050
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMII-CD34 Kit

ADAMII™-CD34 Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540634
Basic UDI-DI: B-08809317540634
Reference: CD34K-025
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

08809317540276

ADAM-rWBC & ADAM-rWBC Kit

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagent

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540276
Basic UDI-DI: B-08809317540276
Reference: ADAM-rWBC & ADAM-rWBC Kit
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

ADAM-rWBC Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540269
Basic UDI-DI: B-08809317540269
Reference: AD1K-050
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

FOB/TF Rapid Test Cassette(Colloidal Gold)

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698402406
Basic UDI-DI: B-06977698402406
Reference: GKPD045
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

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FOB Rapid Test Cassette (Colloidal Gold)

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698402437
Basic UDI-DI: B-06977698402437
Reference: GKPD046
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Assay Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838800952
Basic UDI-DI: B-06975838800952
Reference: HE50102
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Czechia
Authorised representative: MedPath GmbH
Last updated: 07.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Assay Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838800938
Basic UDI-DI: B-06975838800938
Reference: HE50103
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Czechia
Authorised representative: MedPath GmbH
Last updated: 07.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

06975569870088

SXHA610

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sinseng Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000024231
UDI-DI: 06975569870088
Basic UDI-DI: B-06975569870088
Reference: SXHA610
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975569870040

HAS310

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sinseng Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000024231
UDI-DI: 06975569870040
Basic UDI-DI: B-06975569870040
Reference: HAS310
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

Reticulonac

Stain reagent

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: NIHON KOHDEN FIRENZE S.r.l.
Manufacturer SRN: IT-MF-000007607
UDI-DI: 08054615271005
Basic UDI-DI: 805461527IVD0005B8
Reference: MK-110WI
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 10:11

Manufacturer products View details

Testing pack

1 Tests/Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674896983
Basic UDI-DI: 69746748900192A4
Reference: A060030
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450619

DxLab-2A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450619
Basic UDI-DI: 697222145061FJ
Reference: DxLab-2A
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450596

RTisochip-W

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450596
Basic UDI-DI: 697222145059FX
Reference: RTisochip-W
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450480

RTisochipTM-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450480
Basic UDI-DI: 697222145048FS
Reference: RTisochipTM-A
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450381

LuxScan 10K/A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450381
Basic UDI-DI: 697222145038FP
Reference: LuxScan 10K/A
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Dye

D-80FN(M) 6mL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377302806
Basic UDI-DI: 697049309W01030000029AE
Reference: XQ-0064-02
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
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

BH-FD68 Fluorescent dye

BH-FD68

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740726559
Basic UDI-DI: 69357407IBHS000017ED
Reference: /
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
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