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Rc435
EUDAMEDClass I (EU MDR)
Ref RC435Model Threshold cable for cardiac stimulation
by FIAB S.p.A.
Identity
- Model / Reference
- Threshold cable for cardiac stimulation EUDAMEDRC435 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054953347691 EUDAMED
- Basic UDI-DI
- 803300326105000027MP EUDAMED
- EMDN Code
- Z12050680 NON-IMPLANTABLE CARDIAC STIMULATORS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Rc435 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 | 803300326105000027MP | Class I | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED 28adf5b5-3594-469d-9d90-8d18487db06e 61 fields · synced Jun 18, 2026