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Electric Wheelchair
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref Ergo 08L 3.0Model F308, F309, F310, E08P510(k) K250758
Identity
- Trade Name
- ELECTRIC WHEELCHAIR EUDAMED
- Model / Reference
- F308, F309, F310, E08P EUDAMEDErgo 08L 3.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975657161104 EUDAMED
- Basic UDI-DI
- 697565716wheelchairFY EUDAMED
- Direct Marketing DI
- 06975657161104 EUDAMED
- EMDN Code
- Z130106 DRY THERMAL PRINTER X-RAY FILMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Wheelchair by Changshu Pingfang Wheelchair 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 | K250758 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697565716wheelchairFY | Class I | Active |
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Manufacturer
- Manufacturer
- Changshu Pingfang Wheelchair Co., Ltd.
- EUDAMED SRN
- CN-MF-000035424
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (2)
- EUDAMED 22e843cc-d13b-43d2-830d-3405a0fdf02d 85 fields · synced Jun 18, 2026
- FDA 510(k) K250758 1 fields · synced May 18, 2026