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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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03.08.2026 02:01

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R1:37mL×1 R2:10mL×1；1mL×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R073112C
Basic UDI-DI: B-R073112C
Reference: R07311
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:57

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 30ml×4, R2: 15ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R03219ZQ
Basic UDI-DI: B-R03219ZQ
Reference: R03219
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 40ml×4, R2: 18ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R03218ZN
Basic UDI-DI: B-R03218ZN
Reference: R03218
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 60ml×4, R2: 30ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R03217ZL
Basic UDI-DI: B-R03217ZL
Reference: R03217
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 25ml×4, R2: 25ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R03216ZJ
Basic UDI-DI: B-R03216ZJ
Reference: R03216
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 20ml×4, R2: 20ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R03215ZG
Basic UDI-DI: B-R03215ZG
Reference: R03215
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

R1：50ml×4，R2：25ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R03214ZE
Basic UDI-DI: B-R03214ZE
Reference: R03214
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

R1：40ml×4，R2：20ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R03212ZA
Basic UDI-DI: B-R03212ZA
Reference: R03212
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Homocysteine

IVDR_67_LLB_DUB-C_B_KIT_Homocysteine

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961620
Basic UDI-DI: 0405686901388VZ
Reference: 10381040
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem H-FABP

AutoChem H-FABP

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253006245
Basic UDI-DI: B-06942253006245
Reference: 360105HFP000S
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL N-terminal Pro-Brain Natriuretic Peptide Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_LNTP

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768029912
Basic UDI-DI: 0405686901272VD
Reference: 10464526
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Myoglobin (MYO)

IVDR_67_TTN_DUB-C_C_KIT_MYO

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599670
Basic UDI-DI: 0405686900807VR
Reference: 10995649
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Myoglobin

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414197180
Basic UDI-DI: 0405686900829W3
Reference: 10310277
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)

IVDR_67_TTN_DUB-C_C_REAG_hCRP2

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414611112
Basic UDI-DI: 0405686902330V9
Reference: 11537224
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Homocysteine (HCY)

IVDR_67_TTN_DUB-C_B_KIT_HCY

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599298
Basic UDI-DI: 0405686901615VM
Reference: 10995606
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S175S3

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S175S3
Basic UDI-DI: B-CNMF000014455-BF-S175S3
Reference: BF-S175
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S174RZ

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S174RZ
Basic UDI-DI: B-CNMF000014455-BF-S174RZ
Reference: BF-S174
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S173RX

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S173RX
Basic UDI-DI: B-CNMF000014455-BF-S173RX
Reference: BF-S173
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S172RV

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S172RV
Basic UDI-DI: B-CNMF000014455-BF-S172RV
Reference: BF-S172
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S171RT

BF S17

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S171RT
Basic UDI-DI: B-CNMF000014455-BF-S171RT
Reference: BF-S171
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:51

Manufacturer products Authorised representative products Authorised representative actors View details