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manual wheelchairs
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref SYIV100A008510(k) K252517
Identity
- Device Name
- manual wheelchairs EUDAMED
- Model / Reference
- SYIV100A008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950572844080 EUDAMED
- Basic UDI-DI
- 695057284408JS EUDAMED
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
manual wheelchairs by Ningbo Shenyu Medical Equipment 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 | K252517 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 695057284408JS | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Shenyu Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000003330
- FDA Applicant
- Ningbo Shenyu Medical Equipment Co.,Ltd
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ed09586d-5f4d-4152-b940-a0f08be912e5 85 fields · synced Oct 6, 2026
- FDA 510(k) K252517 1 fields · synced May 18, 2026