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50011
EUDAMEDClass I (EU MDR)
Ref 50011Model Insulating protection for heart wires
by FIAB S.p.A.
Identity
- Model / Reference
- Insulating protection for heart wires EUDAMED50011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033003268063 EUDAMED
- Basic UDI-DI
- 803300326105000002M7 EUDAMED
- EMDN Code
- C020299 CARDIAC TEMPORARY STIMULATION DEVICES (WITH OR WITHOUT ACTIVE SUBSTANCES) - OTHER 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
50011 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 | 803300326105000002M7 | Class I | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED 56a7ad4a-a87c-4e84-bc7c-d22c8dd989bc 61 fields · synced Jul 16, 2026