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BioFreedom
EUDAMEDClass III (EU MDR)
Ref BFR1-2542Ref BFR1-2518Ref BFR1-2724Ref BFR1-3548Ref BFR1-3033Ref BFR1-2742Ref BFR1-2708Ref BFR1-2514Ref BFR1-2508Ref BFR1-2748Ref BFR1-2548Ref BFR1-4014Ref BFR1-2536Ref BFR1-3536Ref BFR1-3533Ref BFR1-3018Ref BFR1-2208Ref BFR1-3024Ref BFR1-3524Ref BFR1-3008Ref BFR1-3514Ref BFR1-3028Ref BFR1-2228Ref BFR1-3048Ref BFR1-2711Ref BFR1-2218Ref BFR1-4008Ref BFR1-2211Ref BFR1-2524Ref BFR1-4011Ref BFR1-3511Ref BFR1-2214Ref BFR1-4018
Identity
- Trade Name
- BioFreedom Drug Coated Coronary Stent System EUDAMED
- Device Name
- BioFreedom EUDAMEDBioFreedom Drug Coated Coronary Stent System EUDAMED
- Model / Reference
- BFR1-2542 EUDAMEDBFR1-2518 EUDAMEDBFR1-2724 EUDAMEDBFR1-3548 EUDAMEDBFR1-3033 EUDAMEDBFR1-2742 EUDAMEDBFR1-2708 EUDAMEDBFR1-2514 EUDAMEDBFR1-2508 EUDAMEDBFR1-2748 EUDAMEDBFR1-2548 EUDAMEDBFR1-4014 EUDAMEDBFR1-2536 EUDAMEDBFR1-3536 EUDAMEDBFR1-3533 EUDAMEDBFR1-3018 EUDAMEDBFR1-2208 EUDAMEDBFR1-3024 EUDAMEDBFR1-3524 EUDAMEDBFR1-3008 EUDAMEDBFR1-3514 EUDAMEDBFR1-3028 EUDAMEDBFR1-2228 EUDAMEDBFR1-3048 EUDAMEDBFR1-2711 EUDAMEDBFR1-2218 EUDAMEDBFR1-4008 EUDAMEDBFR1-2211 EUDAMEDBFR1-2524 EUDAMEDBFR1-4011 EUDAMEDBFR1-3511 EUDAMEDBFR1-2214 EUDAMEDBFR1-4018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08888893028620 EUDAMED08888893014487 EUDAMED08888893014579 EUDAMED08888893028699 EUDAMED08888893014678 EUDAMED08888893028644 EUDAMED08888893014531 EUDAMED08888893014470 EUDAMED08888893014456 EUDAMED08888893028651 EUDAMED08888893028637 EUDAMED08888893014791 EUDAMED08888893014524 EUDAMED08888893014760 EUDAMED08888893014753 EUDAMED08888893014647 EUDAMED08888893014395 EUDAMED08888893014654 EUDAMED08888893014739 EUDAMED08888893014616 EUDAMED08888893014715 EUDAMED08888893014661 EUDAMED08888893014449 EUDAMED08888893028675 EUDAMED08888893014548 EUDAMED08888893014425 EUDAMED08888893014777 EUDAMED08888893014401 EUDAMED08888893014494 EUDAMED08888893014784 EUDAMED08888893014708 EUDAMED08888893014418 EUDAMED08888893014807 EUDAMED
- Basic UDI-DI
- B-08888893028620 EUDAMEDB-08888893014487 EUDAMEDB-08888893014579 EUDAMEDB-08888893028699 EUDAMEDB-08888893014678 EUDAMEDB-08888893028644 EUDAMEDB-08888893014531 EUDAMEDB-08888893014470 EUDAMEDB-08888893014456 EUDAMEDB-08888893028651 EUDAMEDB-08888893028637 EUDAMEDB-08888893014791 EUDAMEDB-08888893014524 EUDAMEDB-08888893014760 EUDAMEDB-08888893014753 EUDAMEDB-08888893014647 EUDAMEDB-08888893014395 EUDAMEDB-08888893014654 EUDAMEDB-08888893014739 EUDAMEDB-08888893014616 EUDAMEDB-08888893014715 EUDAMEDB-08888893014661 EUDAMEDB-08888893014449 EUDAMEDB-08888893028675 EUDAMEDB-08888893014548 EUDAMEDB-08888893014425 EUDAMEDB-08888893014777 EUDAMEDB-08888893014401 EUDAMEDB-08888893014494 EUDAMEDB-08888893014784 EUDAMEDB-08888893014708 EUDAMEDB-08888893014418 EUDAMEDB-08888893014807 EUDAMED8888893BFR1FW 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
No
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 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-08888893028620 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-08888893028620 | 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 (34)
- EUDAMED 3c83acab-9e2b-4f25-abc1-82ef92ef4d76 61 fields · synced Oct 7, 2026
- EUDAMED f3849e02-cdf3-401d-93ff-f590bd06290f 61 fields · synced May 11, 2026
- EUDAMED 04e73e70-0f5e-4730-8b64-b9c705a66b08 61 fields · synced May 11, 2026
- EUDAMED 9b091060-db03-4394-ba9b-92beda9ca445 61 fields · synced May 16, 2026
- EUDAMED 76461494-c137-4a41-bbb6-d543369c6abf 61 fields · synced May 16, 2026
- EUDAMED 40005694-161c-4439-8f71-215a2b11e5bb 61 fields · synced May 17, 2026
- EUDAMED aa8bf9f4-5056-4fea-b6f8-e775b72db042 61 fields · synced May 17, 2026
- EUDAMED 52aee4a7-ce1f-40a1-951c-b3263ffef21e 61 fields · synced May 17, 2026
- EUDAMED c4e9dcea-91cd-4a5e-a388-e01327f85836 61 fields · synced May 17, 2026
- EUDAMED 13fa0da3-bb01-4a49-82a6-1878f707f928 61 fields · synced May 17, 2026
- EUDAMED 26ced740-4953-4714-b273-ea4fe9894516 61 fields · synced May 17, 2026
- EUDAMED 7b8572a7-e910-48e4-ba5a-06e9733872c3 61 fields · synced May 17, 2026
- EUDAMED 3bda9038-cb7e-4def-95b6-915ec7f4dc47 61 fields · synced May 17, 2026
- EUDAMED 5a82eff0-8838-4aef-b49d-dff20bf562cc 61 fields · synced May 17, 2026
- EUDAMED ff43073f-2a46-408d-bcb6-f1b5e2b42751 61 fields · synced May 17, 2026
- EUDAMED 0a50e098-7812-45a6-bf39-83add5f89d2f 61 fields · synced May 17, 2026
- EUDAMED 9eb667f6-37a0-4f3f-be56-68347bf29f9a 61 fields · synced May 17, 2026
- EUDAMED 180897d7-44b2-4c3d-8312-f10f3ffe7e05 61 fields · synced May 17, 2026
- EUDAMED 18b90890-bbf2-4efe-b2c0-5b2b75c03055 61 fields · synced May 17, 2026
- EUDAMED 9b2d6586-3278-43b6-a523-dee36673fc4e 61 fields · synced May 18, 2026
- EUDAMED e81e1e91-122f-43cc-8403-40e5b66e8cca 61 fields · synced May 18, 2026
- EUDAMED b8b0f56f-9af8-476c-b7f4-1bb4516d2e52 61 fields · synced May 18, 2026
- EUDAMED 8d779b4f-f1b4-4138-9dc6-84d765c5e72a 61 fields · synced May 18, 2026
- EUDAMED 978873e7-fcf1-44ab-b0b7-d988773e12f3 61 fields · synced May 18, 2026
- EUDAMED 0163e0a9-1807-40f2-ae38-9aae72728515 61 fields · synced May 18, 2026
- EUDAMED 11fa0f42-4429-461f-ba3d-47448ec95398 61 fields · synced May 18, 2026
- EUDAMED b8861b2d-bc5e-41ef-b796-90569148d4f1 61 fields · synced May 18, 2026
- EUDAMED 91278b14-77d6-44ee-8db2-c0517ba59ac0 61 fields · synced May 18, 2026
- EUDAMED 90c30244-6d5f-4ab6-a84a-ac29ca40a8ee 61 fields · synced May 19, 2026
- EUDAMED 61e9c8a3-c5c5-48de-898d-edc95ebf53c0 61 fields · synced May 19, 2026
- EUDAMED 838daef9-cdeb-4d7d-9e44-0edb92795c45 61 fields · synced May 19, 2026
- EUDAMED e7ad64d3-4e73-4300-a267-38210362fc2b 61 fields · synced May 19, 2026
- EUDAMED b6709767-23fc-4d14-a3b9-9090c5cfc4e0 61 fields · synced May 19, 2026
- EUDAMED 9f0cc06e-674c-4423-ab1f-ef89ee6d4bae 61 fields · synced Oct 7, 2026