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Earpad covers
EUDAMEDClass I (EU MDR)
Ref FF1075Ref SS1101Model Biocompatible earpad covers
by FIM Medical
Identity
- Trade Name
- Earpad covers EUDAMED
- Device Name
- Earpad covers EUDAMEDBiocompatible earpad covers EUDAMED
- Model / Reference
- FF1075 EUDAMEDBiocompatible earpad covers EUDAMEDSS1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760253450324 EUDAMED
- Basic UDI-DI
- 376025345FF1075TU EUDAMEDB-03760253450324 EUDAMED
- EMDN Code
- Z12149080 VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Earpad covers by FIM Medical — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 376025345FF1075TU | Class I | Active |
| EUDAMED | European Union | CE/MDR | 376025345FF1075TU | Class I | Active |
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Manufacturer
- Manufacturer
- FIM Medical
- EUDAMED SRN
- FR-MF-000017090
Sources (2)
- EUDAMED 731aeae2-8055-4e30-9cb2-c018c6fc6909 61 fields · synced Jul 30, 2026
- EUDAMED 2e7ca625-aafc-483c-8a5c-16f525aa7fec 61 fields · synced May 19, 2026