Identity
- Device Name
- BioFreedom Ultra EUDAMED
- Model / Reference
- BFC1-3536 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08888893024172 EUDAMED
- Basic UDI-DI
- B-08888893024172 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
BioFreedom Ultra by Biosensors Europe SA — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08888893024172 | 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 (1)
- EUDAMED 76986891-7ac3-4da2-9ff1-5aad5c7491f9 61 fields · synced Jun 17, 2026