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G014
EUDAMEDClass I (EU MDR)
Ref G014Model Gel for ECG, EEG, EMG and defibrillation
by FIAB S.p.A.
Identity
- Model / Reference
- Gel for ECG, EEG, EMG and defibrillation EUDAMEDG014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054242442199 EUDAMED
- Basic UDI-DI
- 803300326130000005LH EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
G014 by FIAB 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 | 803300326130000005LH | Class I | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED 954c0661-b4c8-4cf0-875a-f2ef5e57320b 61 fields · synced Jul 9, 2026