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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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05.08.2026 00:40

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R1: 1mL×10, R2: 15mL×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R01016YS
Basic UDI-DI: B-R01016YS
Reference: R01016
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1mL×5, R2: 15mL×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R01015YQ
Basic UDI-DI: B-R01015YQ
Reference: R01015
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

R1:10mL×10，R2:60mL×2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R01014YN
Basic UDI-DI: B-R01014YN
Reference: R01014
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

R1:5mL×10，R2:60mL×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R01013YL
Basic UDI-DI: B-R01013YL
Reference: R01013
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

R1:4ml×10,R2:50ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R01012YJ
Basic UDI-DI: B-R01012YJ
Reference: R01012
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

R1:2ml×10,R2:30ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R01011YG
Basic UDI-DI: B-R01011YG
Reference: R01011
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Control

D-dimer Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762575
Basic UDI-DI: 697134876234B25752F
Reference: MF-234
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

Thromboplastin L

-

IVD Class CNot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013016779
Basic UDI-DI: 505601300PTMR
Reference: 5267L
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Ireland
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

Thromboplastin L

-

IVD Class CNot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013017424
Basic UDI-DI: 505601300PTMR
Reference: 5265HL
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

FIBRINÓGENO

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155007811
Basic UDI-DI: B-18430155007811
Reference: 999430
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Spain
Authorised representative: -
Last updated: 20.07.2026 07:37

Manufacturer products View details

Antithrombin III (AT Ⅲ) Assay Kit (Chromogenic Substrate Method)

105-023634-00、105-023635-00、105-023636-00、105-023637-00、105-023640-00、105-023641-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053163323
Basic UDI-DI: 69449040AB75000075X
Reference: 105-013241-00
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 20.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Activated Partial Thromboplastin Time (APTT) Assay Kit (Clotting Method)

105-023616-00、105-023617-00、105-023618-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025720
Basic UDI-DI: 69449040AB75000045R
Reference: 105-029077-00
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 20.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

D-Dimer Turbi Latex

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041019468
Basic UDI-DI: B-62230041019468
Reference: 585 001
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 20.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

BF S06

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460303
Basic UDI-DI: B-06935784460303
Reference: BF-S061
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the market

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247281156
Basic UDI-DI: 69382472IBS-13L8
Reference: 876E
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 18.07.2026 13:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Fast Test Kit (Immunofluorescence Assay)

D-Dimer Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792461
Basic UDI-DI: 695441471339HV
Reference: IF5006
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

Antiserum to Human Plasminogen

IVDR_27_MAR EB_B_REAG_AS_Plasm

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414238302
Basic UDI-DI: 0405686902152V9
Reference: 10873656
EMDN: W0103020505
EMDN description: PLASMINOGEN
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 23:43

Manufacturer products View details

Antiserum to Human Antithrombin III

IVDR_27_MAR EB_C_REAG _AS_ATIII

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414238296
Basic UDI-DI: 0405686902149VL
Reference: 10873655
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 23:43

Manufacturer products View details

Antiserum to Human Fibrinogen

IVDR_27_MAR EB_C_REAG_AS_FIB

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414238289
Basic UDI-DI: 0405686902151V7
Reference: 10873654
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 23:43

Manufacturer products View details

CALIBRADOR DE COAGULACIÓN

CALIBRADOR DE COAGULACIÓN

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155011153
Basic UDI-DI: B-18430155011153
Reference: 990945
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 23:36

Manufacturer products View details