Identity
- Trade Name
- KHEIRON EUDAMED
- Device Name
- Ø6 patient-specific K-ROD Ti rod EUDAMED
- Model / Reference
- 32KR60000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701313000462 EUDAMED
- Basic UDI-DI
- B-03701313000462 EUDAMED
- EMDN Code
- P09070199 SPINAL FUSION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Kheiron by S.m.a.i.o — Class IIb — 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-03701313000462 | Class IIb | Active |
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Manufacturer
- Manufacturer
- S.m.a.i.o
- EUDAMED SRN
- FR-MF-000002399
Sources (1)
- EUDAMED ea39aa70-ca02-4324-8df1-985c564a00ec 61 fields · synced May 23, 2026