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530558
EUDAMEDClass IIa (EU MDR)
Ref 530558Model Peel-Away percutaneous introduction set
by FIAB S.p.A.
Identity
- Model / Reference
- Peel-Away percutaneous introduction set EUDAMED530558 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054751933744 EUDAMED
- Basic UDI-DI
- 803300326222000007MT EUDAMED
- EMDN Code
- C0503 CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY 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
530558 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 | 803300326222000007MT | Class IIa | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED 6d64cce8-9423-4a9c-89a3-8df94a30989d 61 fields · synced Jul 17, 2026