Identity
- Trade Name
- Speedboat Ultraslim EUDAMED
- Device Name
- Speedboat Electrosurgical Instrument EUDAMED
- Model / Reference
- PRD-SB1-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060359560810 EUDAMED
- Basic UDI-DI
- 506035956SPEEDBOATINRS2G3 EUDAMED
- EMDN Code
- K0299 ELECTROSURGERY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Speedboat Ultraslim by Creo Medical — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 506035956SPEEDBOATINRS2G3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Creo Medical
- EUDAMED SRN
- GB-MF-000019076
- Authorised Representative
- Creo Medical, S.L.U. ES-AR-000001355
Sources (1)
- EUDAMED 36713d92-527e-452e-8a08-bb3aa888173a 61 fields · synced Aug 4, 2026