Identity
- Trade Name
- EFLM-ME-04B-S EUDAMED
- Device Name
- EFLM-ME-04B-S EUDAMED
- Model / Reference
- EFLM-ME-04B-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054188641854 EUDAMED
- Basic UDI-DI
- B-08054188641854 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Eflm-Me-04b-S by Eufoton Srl — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08054188641854 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eufoton Srl
- EUDAMED SRN
- IT-MF-000009227
Sources (1)
- EUDAMED 8cad43db-0076-4fca-a91a-cac50ae7fe25 61 fields · synced Jul 16, 2026