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Aquaplast RT™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-1931-4Model Thermoplastic Bolus
by Qfix
Identity
- Trade Name
- Aquaplast RT™ FDA UDI
- Generic Name
- Radiation therapy bolus, single-use FDA UDI
- Device Name
- Aquaplast RT Custom Bolus, 4.8mm, 30cm x 45cm FDA UDI
- Model / Reference
- RT-1931-4 EUDAMEDFDA UDIThermoplastic Bolus EUDAMED
- Description
- Aquaplast RT Custom Bolus, 4.8mm, 30cm x 45cm FDA UDI
Identifiers
- Catalog Number
- RT-1931-4 FDA UDI
- Primary DI / UDI-DI
- 10841962117637 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621THERMOBOLUS9V EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Radiation therapy bolus, single-use 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
Yes
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
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 Safe FDA UDI
Dimensions & Sizes
- Size
- Depth — 4.8 Millimeter FDA UDILength — 30 Inch FDA UDIWidth — 45 Inch FDA UDI
Category: Radiation therapy bolus, single-use
Aquaplast RT™ by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiation therapy bolus, single-use.
- Clearsight Bolus — CLEARSIGHT RT LLC · Class I
- Clearsight Bolus — CLEARSIGHT RT LLC · Class I
- Clearsight Bolus — CLEARSIGHT RT LLC · Class I
- TrueFit Bolus — Adaptiiv Medical Technologies Inc · Class II
- Clearsight Bolus — CLEARSIGHT RT LLC · Class I
- VSP Bolus — 3D SYSTEMS, INC. · Class II
- Clearsight Bolus — CLEARSIGHT RT LLC · Class I
- Clearsight Bolus — CLEARSIGHT RT LLC · Class I
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 6330a60d-92c0-47b1-b533-fb388e3b6638 36 fields · synced Jun 19, 2026
- EUDAMED 649e6dbf-3d7a-4380-a80f-d8f328cecda1 61 fields · synced Jun 19, 2026