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Rondella Ad Interfaccia Liscia St
EUDAMEDClass I (EU MDR)
Ref 5000036STModel Accessorio
by Mikai s.p.a.
Identity
- Trade Name
- RONDELLA AD INTERFACCIA LISCIA ST EUDAMED
- Device Name
- FEP EUDAMED
- Model / Reference
- Accessorio EUDAMED5000036ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056630554408 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
Rondella Ad Interfaccia Liscia 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 |
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Manufacturer
- Manufacturer
- Mikai s.p.a.
- EUDAMED SRN
- IT-MF-000030732
Sources (1)
- EUDAMED b3757c5f-8e69-4ba8-9c7d-63627e496e1f 61 fields · synced Jun 19, 2026