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Fiber Optic for PLA Long (Red)
EUDAMEDClass IIa (EU MDR)
Ref EI KT0 0010 320Model EI KT0 0010 xxx
by ELESTA SpA
Identity
- Trade Name
- Fiber Optic for PLA Long (Red) EUDAMED
- Device Name
- Fiber Optic for PLA EUDAMED
- Model / Reference
- EI KT0 0010 xxx EUDAMEDEI KT0 0010 320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052286590357 EUDAMED
- Basic UDI-DI
- 805228659EIKT00010xxx5A EUDAMED
- EMDN Code
- Z12011080 LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
Fiber Optic for PLA Long (Red) by Elesta Spa — Class IIa — 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 | 805228659EIKT00010xxx5A | Class IIa | Active |
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Manufacturer
- Manufacturer
- ELESTA SpA
- EUDAMED SRN
- IT-MF-000037909
Sources (1)
- EUDAMED 6f0b3998-9646-43bb-ba30-3926a080c98e 61 fields · synced Jul 9, 2026