Identity
- Trade Name
- U-Frame Mask EUDAMEDAquaCast Mask FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Radiological Positioning Holders, Cradles and Accessories EUDAMEDAquaCast Mask is a device used for the positioning and immobilization of patient’s head undergoing or receiving a course of external beam radiation therapy for the treatment of cancer. Our AquaCast Masks are available in thicknesses of 2.4 mm and 3.2 mm. The thermoplastics extending 5cm and 7cm beyond the bottom of the plastic frames for U-frame, S-frame, V-frame masks are also available for land-marking. FDA UDI
- Model / Reference
- PUS-24 EUDAMEDFDA UDI
- Description
- AquaCast Mask is a device used for the positioning and immobilization of patient’s head undergoing or receiving a course of external beam radiation therapy for the treatment of cancer. Our AquaCast Masks are available in thicknesses of 2.4 mm and 3.2 mm. The thermoplastics extending 5cm and 7cm beyond the bottom of the plastic frames for U-frame, S-frame, V-frame masks are also available for land-marking. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879740172 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987974RT58 EUDAMED
- 510(k) Number
- K252174 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- T030401 RADIOTHERAPY PROTECTION MASKS 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
- Lithuania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
U-Frame Mask by Blessing Cathay Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987974RT58 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Blessing Cathay Corporation
- EUDAMED SRN
- TW-MF-000033419
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 3a117dbf-3732-4e99-9f4d-e896178a846c 61 fields · synced Jul 24, 2026
- FDA UDI f8b87906-bfcd-4a04-8db7-9de1f2763cd4 34 fields · synced May 30, 2026