Identity
- Trade Name
- SPEEDSTAR EUDAMED
- Device Name
- SPEEDSTAR EUDAMED
- Model / Reference
- S053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055384930315 EUDAMED
- Basic UDI-DI
- 805538493S053CJ EUDAMED
- Direct Marketing DI
- 08055384930315 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I 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
Speedstar by Neatech.it — 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 | 805538493S053CJ | Class I | Active |
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Manufacturer
- Manufacturer
- Neatech.it
- EUDAMED SRN
- IT-MF-000031601
Sources (1)
- EUDAMED 89d330ab-16dc-456f-898b-f5d5c849093c 61 fields · synced Jul 30, 2026