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BioFreedom Ultra
EUDAMEDClass III (EU MDR)
Ref BFC1-2509Ref BFC1-2536Ref BFC1-2709Ref BFC1-2524Ref BFC1-3519Ref BFC1-3019Ref BFC1-3029Ref BFC1-4029Ref BFC1-2719Ref BFC1-4014Ref BFC1-2533Ref BFC1-3533Ref BFC1-3514Ref BFC1-2519Ref BFC1-2736Ref BFC1-2229Ref BFC1-3009Ref BFC1-2729Ref BFC1-3014Ref BFC1-4019Ref BFC1-2733Ref BFC1-2224
Identity
- Device Name
- BioFreedom Ultra EUDAMED
- Model / Reference
- BFC1-2509 EUDAMEDBFC1-2536 EUDAMEDBFC1-2709 EUDAMEDBFC1-2524 EUDAMEDBFC1-3519 EUDAMEDBFC1-3019 EUDAMEDBFC1-3029 EUDAMEDBFC1-4029 EUDAMEDBFC1-2719 EUDAMEDBFC1-4014 EUDAMEDBFC1-2533 EUDAMEDBFC1-3533 EUDAMEDBFC1-3514 EUDAMEDBFC1-2519 EUDAMEDBFC1-2736 EUDAMEDBFC1-2229 EUDAMEDBFC1-3009 EUDAMEDBFC1-2729 EUDAMEDBFC1-3014 EUDAMEDBFC1-4019 EUDAMEDBFC1-2733 EUDAMEDBFC1-2224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08888893023908 EUDAMED08888893023960 EUDAMED08888893023977 EUDAMED08888893023939 EUDAMED08888893024134 EUDAMED08888893024066 EUDAMED08888893024080 EUDAMED08888893024226 EUDAMED08888893023991 EUDAMED08888893024196 EUDAMED08888893023953 EUDAMED08888893024165 EUDAMED08888893024127 EUDAMED08888893023922 EUDAMED08888893024035 EUDAMED08888893023892 EUDAMED08888893024042 EUDAMED08888893024011 EUDAMED08888893024059 EUDAMED08888893024202 EUDAMED08888893024028 EUDAMED08888893023885 EUDAMED
- Basic UDI-DI
- B-08888893023908 EUDAMEDB-08888893023960 EUDAMEDB-08888893023977 EUDAMEDB-08888893023939 EUDAMEDB-08888893024134 EUDAMEDB-08888893024066 EUDAMEDB-08888893024080 EUDAMEDB-08888893024226 EUDAMEDB-08888893023991 EUDAMEDB-08888893024196 EUDAMEDB-08888893023953 EUDAMEDB-08888893024165 EUDAMEDB-08888893024127 EUDAMEDB-08888893023922 EUDAMEDB-08888893024035 EUDAMEDB-08888893023892 EUDAMEDB-08888893024042 EUDAMEDB-08888893024011 EUDAMEDB-08888893024059 EUDAMEDB-08888893024202 EUDAMEDB-08888893024028 EUDAMEDB-08888893023885 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-08888893023908 | 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 (22)
- EUDAMED 6d5ed3bb-6c2b-47d4-b5ea-f73e23aafec4 61 fields · synced Oct 7, 2026
- EUDAMED 959b4c67-94e1-4c54-bbe0-4fca5d5af408 61 fields · synced May 11, 2026
- EUDAMED 7dd19c38-00a8-4dd8-a66d-16c82b7e812b 61 fields · synced May 16, 2026
- EUDAMED 1c612190-6d15-4374-a65b-3a77ce25ef7c 61 fields · synced May 16, 2026
- EUDAMED 78becf5a-58a3-403d-9b13-d6b452aed803 61 fields · synced May 16, 2026
- EUDAMED 1d295608-feb2-4336-8b14-a053f3d15293 61 fields · synced May 17, 2026
- EUDAMED 5a0933cc-4c65-4aaf-986c-404a511b32a5 61 fields · synced May 17, 2026
- EUDAMED a0a02e46-7c46-43ab-a493-3e0047b74a69 61 fields · synced May 17, 2026
- EUDAMED e9927ea4-b217-453d-91d6-d2dc90293006 61 fields · synced May 17, 2026
- EUDAMED b28df188-11eb-4487-9844-f8293af06ad9 61 fields · synced May 17, 2026
- EUDAMED 74d864f9-0133-41fb-a918-fcc4ad32e0f6 61 fields · synced May 17, 2026
- EUDAMED b4b149b3-cf8a-4b2e-bae5-1dafe3d13c58 61 fields · synced May 17, 2026
- EUDAMED 45a8f17c-e6a0-4733-8b7d-e0b4f19511f9 61 fields · synced May 17, 2026
- EUDAMED df6c0af9-7faf-45f2-ba75-0a1e8b1bbfd8 61 fields · synced May 17, 2026
- EUDAMED 5779f47b-56ca-4f53-8823-c507bbb0a6c7 61 fields · synced May 18, 2026
- EUDAMED 52a95513-1835-4965-aaca-058979a21adc 61 fields · synced May 18, 2026
- EUDAMED e1dc78a2-62e1-4a99-b22e-7508ffdcb6e7 61 fields · synced May 18, 2026
- EUDAMED 639d1271-67ce-4d24-8a13-627f53e18ff8 61 fields · synced May 18, 2026
- EUDAMED 40758410-ef07-4b3b-be07-9a2a755e0192 61 fields · synced May 18, 2026
- EUDAMED 4857de7e-27c2-4bd8-ab6b-52ce52344902 61 fields · synced May 18, 2026
- EUDAMED 19323890-cc24-46f8-a7cb-1668638e43f1 61 fields · synced May 18, 2026
- EUDAMED fe78194b-c9c4-4b85-abc0-4a85f5603a3a 61 fields · synced May 18, 2026