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Eflm-Pt-04c-S
EUDAMEDClass IIa (EU MDR)
Ref EFLM-PT-04C-SModel Eufoton Optical Fibers Type C
by Eufoton Srl
Identity
- Trade Name
- EFLM-PT-04C-S EUDAMED
- Device Name
- Eufoton Optical Fibers Type C EUDAMED
- Model / Reference
- Eufoton Optical Fibers Type C EUDAMEDEFLM-PT-04C-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054188640659 EUDAMED
- Basic UDI-DI
- 805418864FIBRACODCEZ EUDAMED
- Direct Marketing DI
- 08054188640659 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
The EFLM-PT-04C-S medical device is a Class IIa endoscopic ultrasonic lithotripter designed for the treatment of kidney stones and other urological conditions. It uses high-frequency sound waves to break up and extract kidney stones, providing effective pain relief and improved quality of life for patients.
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 | 805418864FIBRACODCEZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eufoton Srl
- EUDAMED SRN
- IT-MF-000009227
Sources (1)
- EUDAMED d3c79752-c2ff-42b7-8d3d-3ad7fc41f953 61 fields · synced Jul 2, 2026