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04560189213050

ST AIA-PACK D-Dimer CALIBRATOR SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213050
Basic UDI-DI: B-04560189213050
Reference: 0025332
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08436003070726
Basic UDI-DI: 8436003070726XV
Reference: 01R1022
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:43

Manufacturer products View details

D-Dimer Assay Kit

ETGS8601M

IVD Class CIVDR 2017/746Not intended for EU marketKitReagent

Manufacturer: Beijing Strong Biotechnologies, Inc.
Manufacturer SRN: CN-MF-000004362
UDI-DI: 06936736067700
Basic UDI-DI: 697030147BSBE0001H9
Reference: ETGS8601M
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403114
Basic UDI-DI: 697029753047LC
Reference: HGCL05
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Assay Kit (Immunoturbidimetry Method)

105-023628-00、105-023629-00、105-023630-00、105-023647-00、105-024608-00、105-024609-00、105-024610-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025461
Basic UDI-DI: 69449040AB75000025M
Reference: 105-023628-00
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603116

D-Dimer (CLIA)

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603116
Basic UDI-DI: 69268026MD71G00001W6
Reference: MCL02201E
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Netherlands
Safety summary (SSCP/SSP): MD66-6-RE29 · Rev. V2.0
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

iFlash-D-dimer

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711360
Basic UDI-DI: 692591270152H9
Reference: C86238
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Celltac chemi D-dimer DD-421W

D-DIMER

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921050675
Basic UDI-DI: 4931921IVD0026P3
Reference: DD-421W
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

sthemO DDi M

sthemO DDi

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450012347
Basic UDI-DI: 36074509DDI00054J
Reference: 01234
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:10

Manufacturer products View details

STA® - Liatest® D-Di PLUS

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450006629
Basic UDI-DI: 36074509DDI00044G
Reference: 00662
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:10

Manufacturer products View details

VIDAS® D-Dimer Exclusion II™

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026560799
Basic UDI-DI: 357302BUDI000197TQ
Reference: 30455-02
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

VIDAS® D-Dimer Exclusion II™

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026223564
Basic UDI-DI: 357302BUDI000012SH
Reference: 30455
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:50

Manufacturer products View details

D-Dimer Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819714
Basic UDI-DI: B-06950334819714
Reference: 32027164
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762667
Basic UDI-DI: 697134876034B2667ZC
Reference: MF-034-20
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764685
Basic UDI-DI: 697134876034B2667ZC
Reference: MF-034-25
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-DIMER

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673792312
Basic UDI-DI: B-08431673792312
Reference: 1709231
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:25

Manufacturer products View details

D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762230
Basic UDI-DI: B-06971348762230
Reference: MF-34-25
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760380
Basic UDI-DI: B-06971348760380
Reference: MF-34-20
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Assay Kit (Immunoturbidimetry Method)

105-023628-00、105-023629-00、105-023630-00、105-023647-00、105-024608-00、105-024609-00、105-024610-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025744
Basic UDI-DI: 69449040AB75000025M
Reference: 105-029079-00
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.07.2026 15:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-R1511425

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1511425
Basic UDI-DI: B-R1511425
Reference: R15114
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details