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Bebax
EUDAMEDClass I (EU MDR)
Ref BB10,5LRef BB13,5LRef BB13,5RRef BB14,5LRef BB7,5LRef BB11,5LRef BB16,5RRef BB15,5LRef BB8,5LRef BB12,5RRef BB9LRef BB8LRef BB10RRef BB15,5RRef BB12,5L
by Prim, S.a.
Identity
- Trade Name
- BEBAX EUDAMED
- Device Name
- Ortesis de Pie EUDAMED
- Model / Reference
- BB10,5L EUDAMEDBB13,5L EUDAMEDBB13,5R EUDAMEDBB14,5L EUDAMEDBB7,5L EUDAMEDBB11,5L EUDAMEDBB16,5R EUDAMEDBB15,5L EUDAMEDBB8,5L EUDAMEDBB12,5R EUDAMEDBB9L EUDAMEDBB8L EUDAMEDBB10R EUDAMEDBB15,5R EUDAMEDBB12,5L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680639965 EUDAMED08426680640022 EUDAMED08426680640039 EUDAMED08434048008599 EUDAMED08426680644006 EUDAMED08426680639989 EUDAMED08434048008643 EUDAMED08434048008612 EUDAMED08426680644044 EUDAMED08426680640015 EUDAMED08426680644068 EUDAMED08426680644020 EUDAMED08426680644112 EUDAMED08434048008629 EUDAMED08426680640008 EUDAMED
- Basic UDI-DI
- 843404825ORTESISPIEVD EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN ANKLE-FOOT ORTHOSES EUDAMEDY06121202 ENERGY RETURN ORTHOSES FOR KNEE-ANKLE-FOOT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
No
EUDAMED
Bebax by Prim S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 843404825ORTESISPIEVD | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (42)
- EUDAMED f10b6796-a267-4027-9dbe-f839223df022 61 fields · synced Sep 17, 2026
- EUDAMED e343e1ef-3bb1-4074-8ff0-3d60c3ccb593 61 fields · synced May 16, 2026
- EUDAMED f1a80dfc-8e4c-49e2-aa62-19e5c9b1b735 61 fields · synced May 17, 2026
- EUDAMED 0ca3480d-24c4-469e-a2f7-048895425d91 61 fields · synced May 17, 2026
- EUDAMED 4eb55f6c-aa00-40fb-92ff-18a4b8a5f16a 61 fields · synced May 17, 2026
- EUDAMED e18af344-83e6-45df-9b94-490a0870540c 61 fields · synced May 17, 2026
- EUDAMED 2df5b1fa-25f8-44c6-a6bb-56598806f1ff 61 fields · synced May 17, 2026
- EUDAMED 3afaa949-522f-4775-af4d-6250726631c0 61 fields · synced May 18, 2026
- EUDAMED 9e8b1a3c-dd65-4733-baa2-6f0250ee0e69 61 fields · synced May 18, 2026
- EUDAMED 2614a1ee-691c-4b3b-b247-6f969bcf7acf 61 fields · synced May 18, 2026
- EUDAMED 08f9c0aa-8447-4bb5-b5b7-35cfd0f0db74 61 fields · synced May 18, 2026
- EUDAMED 4606b2b5-1067-48b4-bd2c-998f8242c7fd 61 fields · synced May 18, 2026
- EUDAMED 7fd1ffd4-2ea8-4fa1-a8ff-f407c3eb5094 61 fields · synced May 18, 2026
- EUDAMED aacce014-2753-49cf-bf7a-9457344e6098 61 fields · synced May 18, 2026
- EUDAMED 4e4502b8-9efd-45a3-85f8-b0ada9dceba5 61 fields · synced May 19, 2026
- EUDAMED e343e1ef-3bb1-4074-8ff0-3d60c3ccb593-1 61 fields · synced Jun 9, 2026
- EUDAMED 3afaa949-522f-4775-af4d-6250726631c0-1 61 fields · synced Jun 9, 2026
- EUDAMED e18af344-83e6-45df-9b94-490a0870540c-1 61 fields · synced Jun 10, 2026
- EUDAMED f10b6796-a267-4027-9dbe-f839223df022-1 61 fields · synced Jun 10, 2026
- EUDAMED 0ca3480d-24c4-469e-a2f7-048895425d91-1 61 fields · synced Jun 10, 2026
- EUDAMED f1a80dfc-8e4c-49e2-aa62-19e5c9b1b735-1 61 fields · synced Jun 10, 2026
- EUDAMED 4eb55f6c-aa00-40fb-92ff-18a4b8a5f16a-1 61 fields · synced Jun 10, 2026
- EUDAMED 2614a1ee-691c-4b3b-b247-6f969bcf7acf-1 61 fields · synced Jun 10, 2026
- EUDAMED aacce014-2753-49cf-bf7a-9457344e6098-1 61 fields · synced Jun 10, 2026
- EUDAMED 2df5b1fa-25f8-44c6-a6bb-56598806f1ff-1 61 fields · synced Jun 10, 2026
- EUDAMED 9e8b1a3c-dd65-4733-baa2-6f0250ee0e69-1 61 fields · synced Jun 10, 2026
- EUDAMED 4e4502b8-9efd-45a3-85f8-b0ada9dceba5-1 61 fields · synced Jun 10, 2026
- EUDAMED 7f7b6edb-4bab-4516-84b8-edcca29d8647 61 fields · synced Jul 9, 2026
- EUDAMED fc11814b-af19-42dc-afd4-c94d032ce83c-1 61 fields · synced Jul 9, 2026
- EUDAMED b70e49c2-685a-48ce-b993-b3d158555394-1 61 fields · synced Jul 11, 2026
- EUDAMED 908ddbcc-0e1e-460d-9c09-a84dbd7b0123-1 61 fields · synced Jul 12, 2026
- EUDAMED 66046ef9-2195-418f-8a93-697a347345aa-1 61 fields · synced Jul 15, 2026
- EUDAMED 49377b21-6ae4-4b56-8283-b6c47e2251f3-1 61 fields · synced Jul 20, 2026
- EUDAMED c4f37fbe-dce6-4655-be6c-59898a495c9d 61 fields · synced Jul 22, 2026
- EUDAMED 3deb3d22-a624-44bc-99f6-f6227370ace8-1 61 fields · synced Jul 23, 2026
- EUDAMED 6543f208-acf0-4948-a4aa-c4a863c5df60-1 61 fields · synced Jul 24, 2026
- EUDAMED 8582df81-9807-43e4-80e2-1915735ddf83-1 61 fields · synced Jul 29, 2026
- EUDAMED 548a8cc8-b52c-405c-af41-ced36145142e-1 61 fields · synced Jul 29, 2026
- EUDAMED 876e868f-303d-41fe-99ae-c0826bda13a4-1 61 fields · synced Jul 30, 2026
- EUDAMED 1945c254-3f55-4cc2-8681-28c227925cf8 61 fields · synced Jul 31, 2026
- EUDAMED d884c006-87db-48ce-b1d2-5a21d093f86d-1 61 fields · synced Aug 3, 2026
- EUDAMED 4a6ae753-21dd-491b-9757-868a2f10a5a4-1 61 fields · synced Sep 17, 2026