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09120036860568

CaCl2 25 mM

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036860568
Basic UDI-DI: 912003686TC9C0000001ZM
Reference: 5277015
EMDN: W0103020901
EMDN description: CALCIUM CHLORIDE
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:32

Manufacturer products View details

DG CellMedia

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Diagnostic Grifols, S.A.
Manufacturer SRN: ES-MF-000000784
UDI-DI: 08437014205688
Basic UDI-DI: 843658373CELLMEDIAP7
Reference: 210385
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:52

Manufacturer products 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

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: 06903053025522
Basic UDI-DI: 69449040AB75000075X
Reference: 105-023634-00
EMDN: W0103020602
EMDN description: ANTITHROMBIN
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

Fibrin(ogen) Degradation Products (FDP) Assay Kit (lmmunoturbidimetry Method)

105-023631-00、105-023632-00、105-023633-00、105-023648-00、105-023644-00、105-023645-00、105-023646-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025492
Basic UDI-DI: 69449040AB75000015K
Reference: 105-023631-00
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
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

Coagulation Control

105-023642-00、105-023643-00

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025584
Basic UDI-DI: 69449040AB75000085Z
Reference: 105-023642-00
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
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

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

Fibrinogen (FIB) Assay Kit (Clotting Method)

105-023622-00、105-023623-00、105-023624-00、105-023625-00、105-023626-00、105-023627-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025409
Basic UDI-DI: 69449040AB75000065V
Reference: 105-023622-00
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
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

Thrombin Time (TT) Assay Kit (Clotting Method)

105-023619-00、105-023620-00、105-023621-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025379
Basic UDI-DI: 69449040AB75000035P
Reference: 105-023619-00
EMDN: W0103020103
EMDN description: THROMBIN TIME / REPTILASE / BATROXBIN TIME
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

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: 06903053025348
Basic UDI-DI: 69449040AB75000045R
Reference: 105-023616-00
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
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

Prothrombin Time (PT) Assay Kit (Clotting Method)

105-023613-00、105-023614-00、105-023615-00

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025317
Basic UDI-DI: 69449040AB75000055T
Reference: 105-023613-00
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
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

06938247211139

Imidazole Buffer Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247211139
Basic UDI-DI: 69382472IBS-13L8
Reference: 861E
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06926802614457

Washing Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802614457
Basic UDI-DI: 69268026MD85T0000000001HD
Reference: MCC01001E
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

06926802612613

Prothrombin Time

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802612613
Basic UDI-DI: 69268026MD85U0000000001JC
Reference: MCC00203E
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

06926802610145

Diluent for Coagulation Analysis

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802610145
Basic UDI-DI: 69268026MD81Y0000000001HL
Reference: MCH02505E
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603901

Kaolin Activation Reagent

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603901
Basic UDI-DI: 69268026MD66B00001W7
Reference: MCT00201E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603505

Prothrombin Time

IVD Class CIVDR 2017/746No longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603505
Basic UDI-DI: 69268026MD80B00001U7
Reference: MCC00201E
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: -
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738770
Basic UDI-DI: 692591270344HL
Reference: CC1028
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details