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SofTouch™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-4489KWModel SBRT Devices
by Qfix
Identity
- Trade Name
- SofTouch™ FDA UDI
- Generic Name
- Radiological general body-part positioner FDA UDI
- Device Name
- Indexed Foam Knee Wedge FDA UDI
- Model / Reference
- RT-4489KW EUDAMEDFDA UDISBRT Devices EUDAMED
- Description
- Indexed Foam Knee Wedge FDA UDI
Identifiers
- Catalog Number
- RT-4489KW FDA UDI
- Primary DI / UDI-DI
- 10841962108024 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621SBRT8G EUDAMED
- FDA Product Code
- JAI FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological general body-part positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5770 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Radiological general body-part positioner
SofTouch™ by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radiological general body-part positioner.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI 0d6f6bb7-b86e-4259-b41f-b2e1027c822d 35 fields · synced Jul 9, 2026
- EUDAMED 1c00e724-b77c-42b1-97ef-076ed1d2e986 61 fields · synced Jul 9, 2026