← Back to catalogue
Qfix® Carbon Fiber Pelvis System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-4526SModel Breast and Pelvis
by Qfix
Identity
- Trade Name
- Qfix® Carbon Fiber Pelvis System FDA UDI
- Generic Name
- Radiological pelvis positioner FDA UDI
- Device Name
- Qfix Carbon Fiber Pelvis System Includes Knee Wedge and set of 6” Opti-Handles FDA UDI
- Model / Reference
- RT-4526S EUDAMEDFDA UDIBreast and Pelvis EUDAMED
- Description
- Qfix Carbon Fiber Pelvis System Includes Knee Wedge and set of 6” Opti-Handles FDA UDI
Identifiers
- Catalog Number
- RT-4526S FDA UDI
- Primary DI / UDI-DI
- 10841962108628 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621BREASTPELVISTG EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological pelvis positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological pelvis positioner
Qfix® Carbon Fiber Pelvis System by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological pelvis positioner.
- Positioning Cushion — Medtec LLC · Class II
- HipFix® Baseplate — Medtec LLC · Class II
- Back/Abdomen SatPad™ — Sat Pad Inc. · Class II
- Belly Board MRI — Medtec LLC · Class II
- Prone Thorax Support Cushion — Medtec LLC · Class II
- Groin Piece — Medtec LLC · Class II
- MEDRAD® PRO-TEKT Endorectal Balloon — Bayer Medical Care Inc. · Class I
- Belly Board Flat Cushion — Medtec LLC · Class II
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 2ab77230-cb8c-4bdf-bb32-03d23afa8634 35 fields · synced Jun 19, 2026
- EUDAMED a8bad4fa-a310-4825-b563-83c45509f3bf 61 fields · synced Jun 19, 2026