Identity
- Trade Name
- Sopur SR45 EUDAMEDQuickie SR45 FDA UDI
- Generic Name
- Wheelchair, attendant-driven, non-collapsible FDA UDI
- Device Name
- Manual Wheelchair Tilt EUDAMEDThe QUICKIE® SR45 manual tilt wheelchair features 45° of Intelligent Rotation in Space Technology and a simplified mix of options for an outstanding value. FDA UDI
- Model / Reference
- SR45 EUDAMEDFDA UDI
- Description
- The QUICKIE® SR45 manual tilt wheelchair features 45° of Intelligent Rotation in Space Technology and a simplified mix of options for an outstanding value. FDA UDI
Identifiers
- Catalog Number
- EIZ9 FDA UDI
- Primary DI / UDI-DI
- 00016958053661 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958mwctiltHV EUDAMED
- Direct Marketing DI
- 00016958053661 EUDAMED
- 510(k) Number
- K952641 FDA UDI
- FDA Product Code
- IOR FDA UDI
- EMDN Code
- Y122106 REAR SELF-PROPELLED WHEELCHAIRS EUDAMED
- GMDN Term
- Wheelchair, attendant-driven, non-collapsible FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sopur SR45 by Sunrise Medical (US) LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0016958mwctiltHV | Class I | Active |
| 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
- Sunrise Medical (US) LLC
- EUDAMED SRN
- US-MF-000007254
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (2)
- EUDAMED c4003849-decb-4cb0-a5ef-284f6d15697f 61 fields · synced Jun 20, 2026
- FDA UDI a7531350-f8d3-44b0-99c1-c0fce3f679f2 35 fields · synced May 29, 2026