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EUDAMED Device Search

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D-697994388Ir0833SEW

PT Prothrombin Time Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0833SEW
Basic UDI-DI: B-697994388Ir0833SEW
Reference: Ir083
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840304862
Basic UDI-DI: B-69743840304862
Reference: 3050601
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

CRP-W21-1(25PCS)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712010237Z
Basic UDI-DI: B-69717712010237Z
Reference: CRP-W21-1(25PCS)
EMDN: W0103020607
EMDN description: PROTEIN C
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

DIM-W21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-697177120101684
Basic UDI-DI: B-697177120101684
Reference: DIM-F21(25PCS)
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182719012
Basic UDI-DI: B-62230182719012
Reference: D-856 001
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

PTT Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182717100
Basic UDI-DI: B-62230182717100
Reference: D-705 001
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

PT Reagent ISI 1.5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182716806
Basic UDI-DI: B-62230182716806
Reference: D-707 001
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen-LS Clauss Clotting Time Method

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182715298
Basic UDI-DI: B-62230182715298
Reference: D-708 001
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

Recoplastin ISI 1.0 PT Reagent

624 003

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041031934
Basic UDI-DI: B-62230041031934
Reference: 624 003
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

Recoplastin ISI 1.0 PT Reagent

624 002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041031866
Basic UDI-DI: B-62230041031866
Reference: 624 002
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

Recoplastin ISI 1.0 PT Reagent

624 001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041031798
Basic UDI-DI: B-62230041031798
Reference: 624 001
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

Recoplastin ISI 1.0 PT Reagent

624 000

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041031620
Basic UDI-DI: B-62230041031620
Reference: 624 000
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

PT Reagent (SP-Normoplastin)

614 002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041031170
Basic UDI-DI: B-62230041031170
Reference: 614 002
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

PT Reagent (SP-Normoplastin)

614 001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041031002
Basic UDI-DI: B-62230041031002
Reference: 614 001
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen-LS Clauss Clotting Time Method

631 002

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041020976
Basic UDI-DI: B-62230041020976
Reference: 631 002
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen-LS Clauss Clotting Time Method

631 001

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041020808
Basic UDI-DI: B-62230041020808
Reference: 631 001
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

FIBRINOGEN

590 001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041020730
Basic UDI-DI: B-62230041020730
Reference: 590 001
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

585 004

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041019918
Basic UDI-DI: B-62230041019918
Reference: 585 004
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

585 003

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041019840
Basic UDI-DI: B-62230041019840
Reference: 585 003
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

585 002-1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041019772
Basic UDI-DI: B-62230041019772
Reference: 585 002-1
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details