Identity
- Trade Name
- Set Subiton CIFO EUDAMED
- Device Name
- Sistema estéril de cifoplastía por balón EUDAMED
- Model / Reference
- Balón 10mm EUDAMED880672 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798034466727 EUDAMED
- Basic UDI-DI
- B-07798034466727 EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
No
EUDAMED
Set Subiton CIFO by Laboratorios SL S.A. — Class IIa — 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-07798034466727 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Laboratorios SL S.A.
- EUDAMED SRN
- AR-MF-000023153
- Authorised Representative
- Synergie Ingénierie Médicale FR-AR-000001802
Sources (1)
- EUDAMED e66ba352-381d-428e-99f6-89cda2bc0b61 61 fields · synced Jun 19, 2026