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VacQfix™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-4517-PB4MModel Vacuum Cushions
by Qfix
Identity
- Trade Name
- VacQfix™ FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- VacQfix Cushion, 96 X 55cm, 15L Fill FDA UDI
- Model / Reference
- RT-4517-PB4M EUDAMEDFDA UDIVacuum Cushions EUDAMED
- Description
- VacQfix Cushion, 96 X 55cm, 15L Fill FDA UDI
Identifiers
- Catalog Number
- RT-4517-PB4M FDA UDI
- Primary DI / UDI-DI
- 10841962119310 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621VACQFIX5A EUDAMED
- FDA Product Code
- JAI FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Vacuum-mould patient positioning system 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 96 Centimeter FDA UDIWidth — 55 Centimeter FDA UDITotal Volume — 12 Liter FDA UDI
Category: Vacuum-mould patient positioning system
VacQfix™ by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vacuum-mould patient positioning system.
- Klarity Medical — Klarity Medical Products, LLC · Class II
- Klarity Medical — Klarity Medical Products, LLC · Class II
- Vac-Lok™ Cushion — Medtec LLC · Class II
- Vac-Lok™ Cushion — Medtec LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- Vac-Lok™ Cushion — Medtec LLC · Class II
- VacuumCushion Pos.Strip — MACROMEDICS B.V. · Class II
- Helping Hands ™ — 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 |
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Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI 3ceab74a-d845-4870-87dd-55b32cdbeaa7 36 fields · synced Jul 9, 2026
- EUDAMED 6b0dd99e-ae39-4066-90b7-18a285a64670 61 fields · synced Jul 9, 2026