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Factor XIII Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020764
Basic UDI-DI: B-00816426020764
Reference: KAI-206C
EMDN: W0103020213
EMDN description: COAGULATION FACTOR XIII
First on market country: France
Authorised representative: Advena Limited
Last updated: 11.08.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Coagulation Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021013
Basic UDI-DI: B-00816426021013
Reference: K204C-10M
EMDN: W0103020213
EMDN description: COAGULATION FACTOR XIII
First on market country: France
Authorised representative: Advena Limited
Last updated: 11.08.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Normal Human Control Plasma

Normal Control Plasma

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036861961
Basic UDI-DI: 912003686TC1P00000013P
Reference: 5015007
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Austria
Authorised representative: -
Last updated: 10.08.2026 23:34

Manufacturer products View details

Normal Human Control Plasma

IVD Class CNot specifiedOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036861978
Basic UDI-DI: 912003686TC1P00000013P
Reference: 5015015
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:47

Manufacturer products View details

06926802603819

Rapid Kaolin Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603819
Basic UDI-DI: 69268026MD66E00001XE
Reference: MCT00401E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): MD71-6-T25 · Rev. V2.0
Authorised representative: R Sight B.V.
Last updated: 10.08.2026 18:48

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

06926802603826

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603826
Basic UDI-DI: 69268026MD66E00001XE
Reference: MCT00402E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 10.08.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603833

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603833
Basic UDI-DI: 69268026MD66E00001XE
Reference: MCT00403E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 10.08.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603840

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603840
Basic UDI-DI: 69268026MD66E00001XE
Reference: MCT00404E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 10.08.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603864

Thromboelastography Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603864
Basic UDI-DI: 69268026MD66A00001VS
Reference: MCT00101E
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 10.08.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603871

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603871
Basic UDI-DI: 69268026MD66A00001VS
Reference: MCT00102E
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 10.08.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603888

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603888
Basic UDI-DI: 69268026MD66A00001VS
Reference: MCT00103E
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 10.08.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603895

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603895
Basic UDI-DI: 69268026MD66A00001VS
Reference: MCT00104E
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 10.08.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

AESKULISA® Ethanolamine-GM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500890
Basic UDI-DI: B-04250289500890
Reference: 3209
EMDN: W0103020601
EMDN description: ANTI-PHOSPHOLIPID ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 10.08.2026 16:10

Manufacturer products View details

AESKULISA® Inositol-GM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500883
Basic UDI-DI: B-04250289500883
Reference: 3208
EMDN: W0103020601
EMDN description: ANTI-PHOSPHOLIPID ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 10.08.2026 16:10

Manufacturer products View details

SmarLumi

Plasmin-α2-Antiplasmin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857956
Basic UDI-DI: B-06933289857956
Reference: W393P0007
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Plasmin-α2-Antiplasmin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857949
Basic UDI-DI: B-06933289857949
Reference: W393P0006
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Plasmin-α2-Antiplasmin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857932
Basic UDI-DI: B-06933289857932
Reference: W393P0005
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Plasmin-α2-Antiplasmin Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857925
Basic UDI-DI: B-06933289857925
Reference: W393P0004
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

in-tem

503-02

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagent

Manufacturer: Tem Innovations GmbH
Manufacturer SRN: DE-MF-000012176
UDI-DI: 04260160470044
Basic UDI-DI: B-04260160470044
Reference: 503-02
EMDN: W0103020899
EMDN description: HAEMOSTASIS RT & POC - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 09.08.2026 14:00

Manufacturer products View details

HITAlert Kit

Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: IQ Products BV
Manufacturer SRN: NL-MF-000010812
UDI-DI: 08719327450918
Basic UDI-DI: B-08719327450918
Reference: IQP-396
EMDN: W0103020499
EMDN description: PRIMARY HEMOSTASIS/PLATELET FACTORS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details