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4421
EUDAMEDClass I (EU MDR)
Ref 4421Model Threshold cable for cardiac stimulation
by FIAB S.p.A.
Identity
- Model / Reference
- Threshold cable for cardiac stimulation EUDAMED4421 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054953340593 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
4421 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 e07433c3-62e6-42b9-a165-ec830a61747f 61 fields · synced Jul 18, 2026