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HYPHEN BIOMED

France·FR-MF-000002214

Last updated May 25, 2026

Information

Country
France
Address
155, Rue d'Eragny, Neuville-sur-Oise, France
LinkedIn
—
Facebook
—
Phone
+33 1 34 40 65 10
PRRC Contact
Sophie LECOURT
EUDAMED SRN
FR-MF-000002214
FDA FEI Number
—
DUNS Number
503499167

Catalogue (47)

DeviceModel / ReferenceRegistriesClassStatus
BIOPHEN Antithrombin 5 221105
FDA UDI
Class IIActive
BIOPHEN LMWH Control C4 224201
FDA UDI
Class IIActive
BIOPHEN LMWH Control C3 223801
FDA UDI
Class IIActive
BIOPHEN Antithrombin 2.5 221102
FDA UDI
Class IIActive
BIOPHEN Protein C 5 221205
FDA UDI
Class IIActive
Calcium chloride 0.025M (M/40) AR001K
FDA UDI
N/AActive
Biophen Lmwh Control Low Cii 224401
FDA UDI
Class IIActive
Biophen Abnormal Control Plasma 223301
FDA UDI
Class IIActive
BIOPHEN™ V-L Plasma Calibrator 222401
FDA UDI
Class IIActive
Imidazole buffer AR021K
FDA UDI
N/AActive
HEMOCLOT Quanti. V-L CK065K
FDA UDI
Class IIActive
BIOPHEN LMWH Control Plasma 223001
FDA UDI
Class IIActive
Imidazole buffer AR021M
FDA UDI
N/AActive
Calcium chloride 0.25M (M/4) AR002K
FDA UDI
N/AUnknown
Biophen Normal Control Plasma 223201
FDA UDI
Class IIActive
ZYMUTEST HIA IgG RK040A
FDA UDI
Class IIActive
BIOPHEN UFH Control C1 224101
FDA UDI
Class IIActive
Imidazole buffer AR021L
FDA UDI
N/AActive
Biophen Lmwh Control Low Ci 224301
FDA UDI
Class IIActive
Biophen Heparin 3 221003
FDA UDI
Class IIActive
Imidazole buffer AR021N
FDA UDI
N/AActive
BIOPHEN Heparin Calibrator 222001
FDA UDI
Class IIActive
Biophen Heparin 6 221006
FDA UDI
Class IIActive
Calcium chloride 0.025M (M/40) AR001A
FDA UDI
N/AUnknown
BIOPHEN LMWH Control Low 223701
FDA UDI
Class IIActive
ZYMUTEST HIA IgGAM RK040D
FDA UDI
Class IIActive
BIOPHEN Protein C 2.5 221202
FDA UDI
Class IIUnknown
Calcium chloride 0.025M (M/40) AR001B
FDA UDI
N/AActive
Biophen Plasma Calibrator 222101
FDA UDI
Class IIActive
Imidazole buffer AR021B
FDA UDI
N/AActive
BIOPHEN UFH Calibrator 222301
FDA UDI
Class IIActive
Imidazole buffer AR021A
FDA UDI
N/AUnknown
BIOPHEN UFH Control Plasma 223101
FDA UDI
Class IIActive
Calcium chloride 0.025M (M/40) AR001L
FDA UDI
N/AActive
Calcium chloride 0.25M (M/4) AR002A
FDA UDI
N/AUnknown
BIOPHEN™ V-L Control Plasma 223405
FDA UDI
Class IIActive
ZYMUTEST HIA MonoStrip IgGAM RK041D
FDA UDI
Class IIActive
ZYMUTEST HIA MonoStrip IgG RK041A
FDA UDI
Class IIActive
Biophen Ufh Control C2 223901
FDA UDI
Class IIActive
Zymutest Hia Iggam, Zymutest Igg, Model Rk040d, Rk040a K071255
FDA 510(k)
Class IIActive
Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105 K043007
FDA 510(k)
Class IIActive
Biophen Lmwh Control, Lmwh Control Low, Ufh Control, Heparin Calibrator & Ufh Calibrator K051472
FDA 510(k)
Class IIActive
Biophen Protein C5, C2.5, Models 221205, 221202 K050365
FDA 510(k)
Class IIActive
Biophen Normal And Abnormal Control Plasma; Biophen Plasma Calibrator K043451
FDA 510(k)
Class IIActive
Biophen Heparin 3, Biophen Heparin 6 K050367
FDA 510(k)
Class IIActive
BIOPHEN™ FVIII variant 227102
EUDAMED
Class CActive
Special Calcium Chloride AR036K
EUDAMED
Class AActive

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