Identity
- Trade Name
- Shenyu FDA UDI
- Generic Name
- Wheelchair, attendant/occupant-driven, bimanual-chain-operated, collapsible FDA UDI
- Device Name
- Manual Wheelchairs EUDAMED
- Model / Reference
- SYIV100A011 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950572844110 EUDAMEDFDA UDI
- Basic UDI-DI
- 695057284411JF EUDAMED
- 510(k) Number
- K201461 FDA UDI
- FDA Product Code
- IOR FDA UDI
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
- GMDN Term
- Wheelchair, attendant/occupant-driven, bimanual-chain-operated, collapsible FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Shenyu by Ningbo Shenyu Medical Equipment Co., Ltd — Class I — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo Shenyu Medical Equipment Co., Ltd
Sources (2)
- FDA UDI 8026471e-9244-4dee-aeff-8a8be2de0d6d 33 fields · synced Oct 6, 2026
- EUDAMED d8af0291-2892-47e5-9de6-fd49faee8536 61 fields · synced Jul 21, 2026