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Rm-Ep53p
EUDAMEDClass IIb (EU MDR)
Ref RM-EP53PModel Disposable electrodes defibrillation, cardioversion, cardiac stimulator, ECG
by FIAB S.p.A.
Identity
- Model / Reference
- Disposable electrodes defibrillation, cardioversion, cardiac stimulator, ECG EUDAMEDRM-EP53P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054751932013 EUDAMED
- Basic UDI-DI
- 803300326808000008U7 EUDAMED
- EMDN Code
- C020401 EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS EUDAMED
Classification
- Device Class
- Class IIb 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
Rm-Ep53p by FIAB S.p.A. — Class IIb — 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 | 803300326808000008U7 | Class IIb | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED d894e31d-25f8-4017-ad9c-5603b79f3976 61 fields · synced Jun 17, 2026