Identity
- Device Name
- Acciaio EUDAMED
- Model / Reference
- Filo EUDAMED5000610ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055731434329 EUDAMED
- Basic UDI-DI
- 805573143IMP00000WIRE.SX5 EUDAMED
- EMDN Code
- P09120399 BONE FIXATION WIRES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Acciaio by Mikai s.p.a. — Class IIb — 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 | 805573143IMP00000WIRE.SX5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (1)
- EUDAMED 9795c83f-50eb-4f8b-99a6-af305d975c61 61 fields · synced Jul 12, 2026