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Collagen

Platelet Aggregation -Collagen

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537048760
Basic UDI-DI: 366353700067BM
Reference: AG005K
EMDN: W0103020401
EMDN description: AGGREGATION REAGENTS
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

ZYMUTEST™ HIA (Heparin Induced Antibodies) MonoStrip 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: 03663537046803
Basic UDI-DI: 366353700040AZ
Reference: RK041A
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 21:04

Manufacturer products View details

Special Tris-BSA buffer

Tris-BSA Buffer

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537042621
Basic UDI-DI: 366353700003AT
Reference: AR026K
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

CEPHEN™ LS

aPTT Lupus Sensitive

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537041211
Basic UDI-DI: 366353700066BK
Reference: CK522K
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

CEPHEN™

aPTT

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537041204
Basic UDI-DI: 366353700065BH
Reference: CK512K
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

ZYMUTEST™ HIA (Heparin Induced Antibodies) 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: 03663537018770
Basic UDI-DI: 366353700046BD
Reference: RK040D
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 21:04

Manufacturer products View details

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: 03663537018725
Basic UDI-DI: 366353700056BG
Reference: 221802
EMDN: W0103020208
EMDN description: COAGULATION FACTOR IX
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

Imidazole buffer

Imidazole Buffer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537010446
Basic UDI-DI: 366353700002AR
Reference: AR021L
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

BIOPHEN™ Protein C

Protein C chromogenic

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537008238
Basic UDI-DI: 366353700063BD
Reference: 221205
EMDN: W0103020607
EMDN description: PROTEIN C
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

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: 03663537007972
Basic UDI-DI: 366353700058BL
Reference: 221402
EMDN: W0103020207
EMDN description: COAGULATION FACTOR VIII
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

D-dimer TestKit (Homogeneous Chemiluminescence Immunoassay)

D-dimer Test Kit (Homogeneous Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061608
Basic UDI-DI: B-06974524061608
Reference: HCLIA15124
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 21.09.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer F-DC Diluent

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617476436
Basic UDI-DI: 69506174BL2202437A
Reference: BL2201243: 20 L×1
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

Calcium Chloride 0.025M

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537084782
Basic UDI-DI: 366353700001AP
Reference: AR001L
EMDN: W0103020901
EMDN description: CALCIUM CHLORIDE
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 20:59

Manufacturer products View details

Imidazole buffer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537084843
Basic UDI-DI: 366353700002AR
Reference: AR021N
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 20:59

Manufacturer products View details

Collagen

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537086403
Basic UDI-DI: 366353700067BM
Reference: AG005K
EMDN: W0103020401
EMDN description: AGGREGATION REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 20:59

Manufacturer products View details

Revohem™ FIX chromogenic

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085635
Basic UDI-DI: 366353700056BG
Reference: BP549402
EMDN: W0103020208
EMDN description: COAGULATION FACTOR IX
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 20:59

Manufacturer products View details

ADP

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537086359
Basic UDI-DI: 366353700049BK
Reference: AG001K
EMDN: W0103020401
EMDN description: AGGREGATION REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 20:59

Manufacturer products View details

Imidazole buffer

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082672
Basic UDI-DI: 366353700002AR
Reference: BW582001
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 20:59

Manufacturer products View details

Revohem™ FIX chromogenic

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082665
Basic UDI-DI: 366353700056BG
Reference: BD496632
EMDN: W0103020208
EMDN description: COAGULATION FACTOR IX
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 20:59

Manufacturer products View details

Imidazole buffer

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537083181
Basic UDI-DI: 366353700002AR
Reference: BH367139
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 20:59

Manufacturer products View details