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Electric Scooter
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref DDF103Model DDF100510(k) K252275
Identity
- Trade Name
- ELECTRIC SCOOTER EUDAMED
- Device Name
- Mobility Scooter EUDAMED
- Model / Reference
- DDF100 EUDAMEDDDF103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977027830283 EUDAMED
- Basic UDI-DI
- 697702783NX02Q3 EUDAMED
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Electric Scooter by Zhejiang Nysin Medical Co., Ltd. — Class I — 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 | K252275 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697702783NX02Q3 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Nysin Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000043633
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 603165ce-4680-451c-8acb-4af5e5aee6bf 85 fields · synced Jun 18, 2026
- FDA 510(k) K252275 1 fields · synced May 18, 2026