← Back to catalogue
Elemento Base Dinamizzabile Grande St
EUDAMEDClass I (EU MDR)
Ref 5000068STModel Accessorio
by Mikai s.p.a.
Identity
- Trade Name
- ELEMENTO BASE DINAMIZZABILE GRANDE ST EUDAMED
- Device Name
- FEP EUDAMED
- Model / Reference
- Accessorio EUDAMED5000068ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056630554293 EUDAMED
- Basic UDI-DI
- 805573143FEPACCESSORY.SXA EUDAMED
- EMDN Code
- P0912040102 AXIAL BONE FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Elemento Base Dinamizzabile Grande St by Mikai s.p.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 | 805573143FEPACCESSORY.SXA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (1)
- EUDAMED 02c485ee-9235-4340-82c7-50a27eb8ea03 61 fields · synced Jul 11, 2026