Identity
- Trade Name
- KHEIRON EUDAMED
- Device Name
- Marqueur pédiculaire à boule EUDAMED
- Model / Reference
- PA0050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701313001384 EUDAMED
- Basic UDI-DI
- B-03701313001384 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 I — 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-03701313001384 | Class I | Active |
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Manufacturer
- Manufacturer
- S.m.a.i.o
- EUDAMED SRN
- FR-MF-000002399
Sources (1)
- EUDAMED d93b5a6c-3de8-4c5d-8dc0-34f947b60948 61 fields · synced May 23, 2026