- Manufacturer
- HYPHEN BioMed
- Manufacturer SRN
- FR-MF-000002214
- UDI-DI
- 03663537086175
- Basic UDI-DI
- 366353700014AY
- Reference
- BQ221064
- EMDN
- W0103020701
- EMDN description
- CALIBRATION PLASMA FOR HAEMOSTASIS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 05.08.2026 22:46
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
25.09.2026 02:39
Sync status
Successful
Device
3643226
Actor
47900
Certificate
3410
IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- HYPHEN BioMed
- Manufacturer SRN
- FR-MF-000002214
- UDI-DI
- 03663537086243
- Basic UDI-DI
- 366353700059BN
- Reference
- BU634799
- EMDN
- W0103020309
- EMDN description
- ANTI XA ACTIVITY FOR HEPARIN AND DOAC
- First on market country
- -
- Authorised representative
- -
- Last updated
- 05.08.2026 22:46
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- HYPHEN BioMed
- Manufacturer SRN
- FR-MF-000002214
- UDI-DI
- 03663537086236
- Basic UDI-DI
- 366353700059BN
- Reference
- AL064127
- EMDN
- W0103020309
- EMDN description
- ANTI XA ACTIVITY FOR HEPARIN AND DOAC
- First on market country
- -
- Authorised representative
- -
- Last updated
- 05.08.2026 22:46
IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- HYPHEN BioMed
- Manufacturer SRN
- FR-MF-000002214
- UDI-DI
- 03663537086151
- Basic UDI-DI
- 366353700008B5
- Reference
- AP675507
- EMDN
- W0103020701
- EMDN description
- CALIBRATION PLASMA FOR HAEMOSTASIS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 05.08.2026 22:46
IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- HYPHEN BioMed
- Manufacturer SRN
- FR-MF-000002214
- UDI-DI
- 03663537008290
- Basic UDI-DI
- 366353700038BE
- Reference
- 223101
- EMDN
- W0103020702
- EMDN description
- CONTROL PLASMA FOR HAEMOSTASIS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 05.08.2026 22:46
IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- HYPHEN BioMed
- Manufacturer SRN
- FR-MF-000002214
- UDI-DI
- 03663537068805
- Basic UDI-DI
- 366353700027B9
- Reference
- 225301
- EMDN
- W0103020702
- EMDN description
- CONTROL PLASMA FOR HAEMOSTASIS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 05.08.2026 22:46
IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- HYPHEN BioMed
- Manufacturer SRN
- FR-MF-000002214
- UDI-DI
- 03663537086649
- Basic UDI-DI
- 366353700028BB
- Reference
- BT830756
- EMDN
- W0103020702
- EMDN description
- CONTROL PLASMA FOR HAEMOSTASIS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 05.08.2026 22:46
IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- HYPHEN BioMed
- Manufacturer SRN
- FR-MF-000002214
- UDI-DI
- 03663537085437
- Basic UDI-DI
- 366353700053BA
- Reference
- CP790082
- EMDN
- W0103020602
- EMDN description
- ANTITHROMBIN
- First on market country
- -
- Authorised representative
- -
- Last updated
- 05.08.2026 22:46
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- HYPHEN BioMed
- Manufacturer SRN
- FR-MF-000002214
- UDI-DI
- 03663537085949
- Basic UDI-DI
- 366353700006AZ
- Reference
- AR672059
- EMDN
- W0103020215
- EMDN description
- COAGULATION FACTOR VON WILLEBRAND (AG)
- First on market country
- -
- Authorised representative
- -
- Last updated
- 05.08.2026 22:46
06975237552063
R1:5*2ml R2:5*2ml
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- TAIZHOU STEELLEX BIOTECH CO., LTD.
- Manufacturer SRN
- CN-MF-000023056
- UDI-DI
- 06975237552063
- Basic UDI-DI
- B-06975237552063
- Reference
- 20601
- EMDN
- W0103020503
- EMDN description
- D-DIMER
- First on market country
- Romania
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 05.08.2026 14:44
06975237552056
L2 10*1mL
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- TAIZHOU STEELLEX BIOTECH CO., LTD.
- Manufacturer SRN
- CN-MF-000023056
- UDI-DI
- 06975237552056
- Basic UDI-DI
- B-06975237552056
- Reference
- 10502
- EMDN
- W0103020702
- EMDN description
- CONTROL PLASMA FOR HAEMOSTASIS
- First on market country
- Romania
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 05.08.2026 14:44
SmarLumi
Fibrinogen/Fibrin Degradation Product (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000000689
- UDI-DI
- 06933289858038
- Basic UDI-DI
- B-06933289858038
- Reference
- W395P0007
- EMDN
- W0103020502
- EMDN description
- FIBRINOGEN DEGRADATION PRODUCTS
- First on market country
- Romania
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 05.08.2026 14:20
SmarLumi
Fibrinogen/Fibrin Degradation Product (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000000689
- UDI-DI
- 06933289858021
- Basic UDI-DI
- B-06933289858021
- Reference
- W395P0006
- EMDN
- W0103020502
- EMDN description
- FIBRINOGEN DEGRADATION PRODUCTS
- First on market country
- Romania
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 05.08.2026 14:20
SmarLumi
Fibrinogen/Fibrin Degradation Product (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000000689
- UDI-DI
- 06933289858014
- Basic UDI-DI
- B-06933289858014
- Reference
- W395P0005
- EMDN
- W0103020502
- EMDN description
- FIBRINOGEN DEGRADATION PRODUCTS
- First on market country
- Romania
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 05.08.2026 14:20
SmarLumi
Fibrinogen/Fibrin Degradation Product (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000000689
- UDI-DI
- 06933289858007
- Basic UDI-DI
- B-06933289858007
- Reference
- W395P0004
- EMDN
- W0103020502
- EMDN description
- FIBRINOGEN DEGRADATION PRODUCTS
- First on market country
- Romania
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 05.08.2026 14:20
SmarLumi
Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000000689
- UDI-DI
- 06933289857994
- Basic UDI-DI
- B-06933289857994
- Reference
- W394P0007
- EMDN
- W0103020506
- EMDN description
- PLASMINOGEN ACTIVATOR-INHIBITORS
- First on market country
- Romania
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 05.08.2026 14:20
SmarLumi
Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000000689
- UDI-DI
- 06933289857987
- Basic UDI-DI
- B-06933289857987
- Reference
- W394P0006
- EMDN
- W0103020506
- EMDN description
- PLASMINOGEN ACTIVATOR-INHIBITORS
- First on market country
- Romania
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 05.08.2026 14:20
SmarLumi
Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000000689
- UDI-DI
- 06933289857970
- Basic UDI-DI
- B-06933289857970
- Reference
- W394P0005
- EMDN
- W0103020506
- EMDN description
- PLASMINOGEN ACTIVATOR-INHIBITORS
- First on market country
- Romania
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 05.08.2026 14:20
SmarLumi
Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000000689
- UDI-DI
- 06933289857963
- Basic UDI-DI
- B-06933289857963
- Reference
- W394P0004
- EMDN
- W0103020506
- EMDN description
- PLASMINOGEN ACTIVATOR-INHIBITORS
- First on market country
- Romania
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 05.08.2026 14:20
STic EXPERT HIT 5/20
Milenia QuickLine HIT
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingSingle use
- Manufacturer
- Milenia Biotec GmbH
- Manufacturer SRN
- DE-MF-000028733
- UDI-DI
- 04260177041305
- Basic UDI-DI
- B-04260177041305
- Reference
- MQHIT 1
- EMDN
- W0103020402
- EMDN description
- PLATELET FACTOR 4
- First on market country
- Germany
- Authorised representative
- -
- Last updated
- 05.08.2026 11:43