Aquaplast RT™
FDA UDIEUDAMEDClass II (US FDA UDI)
by Qfix
Identity
- Trade Name
- Aquaplast RT™ FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Aquaplast RT Head Only CURVE S-Frame, 2.4 mm, Standard FDA UDI
- Model / Reference
- RT-1779ESD EUDAMEDFDA UDIAquaplast RT and Fibreplast EUDAMED
- Description
- Aquaplast RT Head Only CURVE S-Frame, 2.4 mm, Standard FDA UDI
Identifiers
- Catalog Number
- RT-1779ESD FDA UDI
- Primary DI / UDI-DI
- 10841962112359 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621RTTHERMOPF EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Patient positioning thermoplastic mould material 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Depth — 2.4 Millimeter FDA UDI
Category: Patient positioning thermoplastic mould material
Aquaplast RT™ by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning thermoplastic mould material.
- Mask OLMCF-4 — MACROMEDICS B.V. · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- Klarity Medical — Klarity Medical Products, LLC · Class II
- Type-S™ Thermoplastic — Medtec LLC · Class II
- Uni-frame® Thermoplastic — Medtec LLC · Class II
- Thermoplastic Mask — IZI MEDICAL PRODUCTS LLC · Class II
- ZENTEC™ Thermoplastic — Medtec LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 e80372b6-9f02-4203-b743-12a718b8584b 36 fields · synced Aug 3, 2026
- EUDAMED 96c534d0-d2fb-40f1-9c27-af82a88dbe2f 61 fields · synced Aug 3, 2026