← Back to catalogue
20191-415
EUDAMEDClass I (EU MDR)
Ref 20191-415Model Sterile disposable cleaning pads for electrosurgery
by FIAB S.p.A.
Identity
- Model / Reference
- Sterile disposable cleaning pads for electrosurgery EUDAMED20191-415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054953347493 EUDAMED
- Basic UDI-DI
- 803300326206000005NM EUDAMED
- EMDN Code
- K0299 ELECTROSURGERY DEVICES, SINGLE-USE - 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
Category: Percutaneous radio-frequency ablation system generator
20191-415 by FIAB S.p.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation system generator.
- OneRF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORP. · Class II
- Mygen™ RF Generator M-3004 — RF Medical Co., Ltd. · Class II
- ATTIVA — ITALIAN ENGINEERING SRL · Class II
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Maestro 4000™ Controller — Boston Scientific · Class III
- SmartAblate™ System CoolFlow® Pump Cable — Stockert GmbH · Class III
- InSeal Sealer/Divider — Innolcon Medical Technology (Suzhou) Co., Ltd. · Class IIb
- Electrosurgical Pencil, Button Switch — DEROYAL INDUSTRIES, INC. · Class IIb
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 | 803300326206000005NM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED 49816138-a8e7-4c94-b832-8e4f5a730a77 61 fields · synced Jun 18, 2026