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Fs Series Manual Wheelchair
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref FS875-46Model FS875-46,FS800LBJPF5,FS951B-56,FS879LAJ-46,FS205LHQ-46,FS980LA-41,FS258LBGPY,FS958LBCGPY-38,FS958LBCGPY-44,FS903LPQF11-46,FS909P-46,FS903LAJPQF9-46,FS863AJPF1-46,FS809P-46,FS805LABJ-46,FS874LPF5-46,FS800LBJF2,FS800LBF3,FS902C-46FS908LABJPF29FS908LABJPF30
Identity
- Device Name
- FS SERIES MANUAL WHEELCHAIR EUDAMED
- Model / Reference
- FS875-46,FS800LBJPF5,FS951B-56,FS879LAJ-46,FS205LHQ-46,FS980LA-41,FS258LBGPY,FS958LBCGPY-38,FS958LBCGPY-44,FS903LPQF11-46,FS909P-46,FS903LAJPQF9-46,FS863AJPF1-46,FS809P-46,FS805LABJ-46,FS874LPF5-46,FS800LBJF2,FS800LBF3,FS902C-46FS908LABJPF29FS908LABJPF30 EUDAMEDFS875-46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938001010312 EUDAMED
- Basic UDI-DI
- 69380010005QR EUDAMED
- EMDN Code
- Y122106 REAR SELF-PROPELLED WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Fs Series Manual Wheelchair by Foshan Dongfang Medical Equipment Manufactory (ltd.) — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K041814 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69380010005QR | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Dongfang Medical Equipment Manufactory Ltd.
- EUDAMED SRN
- CN-MF-000036028
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED fabcfc2c-6899-473c-9e90-a2e1bdc0cb69 61 fields · synced Oct 7, 2026
- FDA 510(k) K041814 1 fields · synced May 18, 2026