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Ablation-fit
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ABFT000510(k) K222938
by R.A.W. Srl
Identity
- Trade Name
- Ablation-fit EUDAMED
- Device Name
- Ablation-fit EUDAMED
- Model / Reference
- ABFT000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052141890127 EUDAMED
- Basic UDI-DI
- 8052141890004ABFTEH EUDAMED
- Direct Marketing DI
- 08052141890127 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Ablation-fit by R.A.W. Srl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222938 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8052141890004ABFTEH | Class IIa | Active |
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Manufacturer
- Manufacturer
- R.A.W. Srl
- EUDAMED SRN
- IT-MF-000027589
- FDA Applicant
- R.A.W. S.R.L
Sources (2)
- EUDAMED 532a9c65-7313-4c0c-9a42-77ecd00fe11e 85 fields · synced Jun 18, 2026
- FDA 510(k) K222938 1 fields · synced May 18, 2026