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113 device results listed.

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Imidazole buffer

Imidazole Buffer

IVD Class AIVDR 2017/746Not intended for EU marketKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085727
Basic UDI-DI: 366353700002AR
Reference: AM949007
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

FIBRIPHEN™ LRT

Fibrinogen

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537083358
Basic UDI-DI: 366353700076BN
Reference: CK585K
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

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BIOPHEN™ FIX

Factor IX (FIX) chromogenic

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537064654
Basic UDI-DI: 366353700056BG
Reference: 221806
EMDN: W0103020208
EMDN description: COAGULATION FACTOR IX
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

BIOPHEN™ FVIII

Factor VIII (FVIII) chromogenic

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537047329
Basic UDI-DI: 366353700058BL
Reference: 221406
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

ZYMUTEST™ HIA (Heparin Induced Antibodies) MonoStrip IgGAM

Heparin-Induced Antibodies - IgGAM

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537046810
Basic UDI-DI: 366353700046BD
Reference: RK041D
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

CEPHEN™

aPTT

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537042232
Basic UDI-DI: 366353700065BH
Reference: CK515L
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

ZYMUTEST™ HIA (Heparin Induced Antibodies) IgG

Heparin Induced Antibodies IgG

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537018763
Basic UDI-DI: 366353700040AZ
Reference: RK040A
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

Revohem™ FIB LRT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085468
Basic UDI-DI: 366353700076BN
Reference: CY738219
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 19:18

Manufacturer products View details

Revohem™ FVIII Bovine

Factor VIII (FVIII) bovine

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537087165
Basic UDI-DI: 366353700097BW
Reference: CQ907801
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ Edoxaban Calibrator Low

Edoxaban Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082382
Basic UDI-DI: 366353700013AW
Reference: 226401
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ Edoxaban Control Low

Edoxaban Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082368
Basic UDI-DI: 366353700031AY
Reference: 225401
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

LIAPHEN™ vWF: Ag

Von Willebrand Factor Antigen (vWF: Ag)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082320
Basic UDI-DI: 366353700006AZ
Reference: 120206
EMDN: W0103020215
EMDN description: COAGULATION FACTOR VON WILLEBRAND (AG)
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ AT anti-(h)-Xa LRT

Antithrombin (AT) activity - AntiXa

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537072253
Basic UDI-DI: 366353700053BA
Reference: 221123
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ DiXaI

Direct Factor Xa inhibitors (DiXaIs)

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537047633
Basic UDI-DI: 366353700054BC
Reference: 221030
EMDN: W0103020309
EMDN description: ANTI XA ACTIVITY FOR HEPARIN AND DOAC
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ Rivaroxaban Plasma Calibrator

Rivaroxaban Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537046445
Basic UDI-DI: 366353700017B6
Reference: 222701
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

BIOPHEN™ Apixaban Control Low

Apixaban Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537068799
Basic UDI-DI: 366353700027B9
Reference: 225201
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details

BIOPHEN™ Apixaban Calibrator Low

Apixaban Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537068775
Basic UDI-DI: 366353700008B5
Reference: 226101
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details

BIOPHEN™ Rivaroxaban Control Plasma

Rivaroxaban Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537046421
Basic UDI-DI: 366353700037BC
Reference: 224501
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details

BIOPHEN™ Heparin LRT

Factor Xa (FXa) inhibitors

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537045394
Basic UDI-DI: 366353700059BN
Reference: 221011
EMDN: W0103020309
EMDN description: ANTI XA ACTIVITY FOR HEPARIN AND DOAC
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details

BIOPHEN™ Arixtra® Control Plasma

Fondaparinux Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537041723
Basic UDI-DI: 366353700028BB
Reference: 224001
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:41

Manufacturer products View details