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35125s
EUDAMEDClass IIa (EU MDR)
Ref 35125SModel Esosoft esophageal lead for cardiac recording and stimulation
by FIAB S.p.A.
Identity
- Model / Reference
- Esosoft esophageal lead for cardiac recording and stimulation EUDAMED35125S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033003267646 EUDAMED
- Basic UDI-DI
- 803300326003000006KN EUDAMED
- EMDN Code
- C020203 TRANSOESOPHAGEAL RECORDING AND STIMULATION LEADS 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
35125s by FIAB S.p.A. — Class IIa — 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 | 803300326003000006KN | Class IIa | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED 162e845d-9c11-45f7-96aa-52ccc5397c8f 61 fields · synced Jul 26, 2026