Identity
- Trade Name
- BioFreedom Ultra Drug Coated Coronary Stent System EUDAMED
- Device Name
- BioFreedom Ultra EUDAMEDBioFreedom Ultra Drug Coated Coronary Stent System EUDAMED
- Model / Reference
- BFC1-2514 EUDAMEDBFC1-2209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08888893023915 EUDAMED
- Basic UDI-DI
- B-08888893023915 EUDAMED8888893BFC1EH EUDAMED
- EMDN Code
- P070402010302 CORONARY DRUG ELUTING STENTS (DES) WITHOUT 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
BioFreedom Ultra 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-08888893023915 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-08888893023915 | 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 91c19535-38ec-4106-8771-2647513ff01b 61 fields · synced Oct 7, 2026
- EUDAMED 9c0e40ff-c208-4387-826a-f52d7a91a0e4 61 fields · synced Oct 7, 2026