HYPHEN BioMed
FR-MF-000002214 · France · Neuville-sur-Oise
HYPHEN BioMed is registered in the European database on medical devices as a manufacturer, with 65 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
Most frequent device types declared: Apixaban Calibrator, Calcium chloride Heparin neutralizing, Control Normal Plasma, Edoxaban Calibrator, Factor VIII (FVIII) bovine.
Devices declared under this manufacturer
- BIOPHEN™ Apixaban Calibrator
- BIOPHEN™ Edoxaban Control Low
- BIOPHEN™ FVIII variant
- BIOPHEN™ Heparin LRT
- BIOPHEN™ LMWH Control Low CI
- BIOPHEN™ LMWH Control Low CII
- BIOPHEN™ Rivaroxaban Control Low
- BIOPHEN™ Rivaroxaban Plasma Calibrator
- Revohem™ Fondaparinux Control
- Revohem™ Anti-Xa LRT
- Revohem™ Control 1 Pro
- Revohem™ Edoxaban Calibrator
Showing 12 of 65 declared devices.
Catalogue references include 222701, 224301, 226201, 227102, AR036K, AZ296682.
European nomenclature codes declared: W0103020702, W0103020701, W0103020309, W0103020602, W0103020207, W0103020215.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | HYPHEN BIOMED SASU (FR) · FDA 3004434070 |
| Devices in EUDAMED | 65 |
| Country of registration | France |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 65 |
|---|---|
| Found in the U.S. device database | 13 |
| Share | 20.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HYPHEN BIOMED |
What it holds in Canada
| Licences on record | 41 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 41 |
| First licensed | 2007-02-20 |
Licence types: Test Kit (30), Device Family (4), Device Group Family (3), Device Group (3).
Licensed under: ARACHIDONIC ACID, ADP, EPINEPHRINE, COLLAGEN, RISTOCETIN, BIOPHEN HEPARIN 3 & 6.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1348148-1 | amended | 2027-12-14 |