Identity
- Trade Name
- BioMatrix Alpha Drug Eluting Coronary Stent System EUDAMED
- Device Name
- BioMatrix Alpha EUDAMEDBioMatrix Alpha Drug Eluting Coronary Stent System EUDAMED
- Model / Reference
- BMX6-2224 EUDAMEDBMX6-2209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08888893018676 EUDAMED
- Basic UDI-DI
- B-08888893018676 EUDAMED8888893BMX6HV EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
BioMatrix Alpha by Biosensors Europe SA — Class III — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08888893018676 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-08888893018676 | Class III | Active |
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Manufacturer
- Manufacturer
- Biosensors Europe SA
- EUDAMED SRN
- CH-MF-000015764
- Authorised Representative
- NVT GmbH DE-AR-000006441
Sources (2)
- EUDAMED 39b61e82-0336-4701-9523-8a2a2732a70d 61 fields · synced Oct 7, 2026
- EUDAMED 98e1d76e-af32-464e-89e5-ab9c0344ffca 61 fields · synced Oct 7, 2026