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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 18:27

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100 device results listed.

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ADVIA 120/2120/2120i CSF Reagent

IVDR_67_TTN_DUB-C_B_REAG_CSF Reagent

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414473444
Basic UDI-DI: 0405686900783W4
Reference: 10320459
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Diluent used for Hematology Analysis(HAS330)

5L、20L（LHAS310/330/360/380 Diluent）

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698405148
Basic UDI-DI: 697769840GKPD0926W
Reference: GKPD092
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Lyse used for Hematology Analysis （Lyse）

500mL（HAS310/330/360/380 Lyse）

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698405087
Basic UDI-DI: 697769840GKPD0916U
Reference: GKPD091
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaner used for Hematology Analysis

50ml、200ml

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698405032
Basic UDI-DI: 697769840GKPD08979
Reference: GKPD089
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Lyse used for Hematology Analysis(LH)

100ml 、250ml（SXHA610/650/660/680 LH Lyse）

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698404981
Basic UDI-DI: 697769840GKPD08877
Reference: GKPD088
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Lyse used for Hematology Analysis（DIFF）

500mL（SXHA610/650/660/680 DIFF Lyse）

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698404936
Basic UDI-DI: 697769840GKPD08775
Reference: GKPD087
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Diluent used for Hematology Analysis

5L、20L（SXHA610/650/660/680 Diluent）

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698404929
Basic UDI-DI: 697769840GKPD08673
Reference: GKPD086
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.07.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

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