Identity
- Trade Name
- Patient Mask Set EUDAMEDFDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Patient Mask Set EUDAMED
- Model / Reference
- 41130 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 41130 FDA UDI
- Primary DI / UDI-DI
- 04056481125967 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481PatientMask38 EUDAMED
- 510(k) Number
- K945903 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
Manufacturing Date
No
Category: Multi-modality therapeutic radiation phantom, test object
Patient Mask Set by Brainlab SE — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-modality therapeutic radiation phantom, test object.
- QUASAR — Modus Medical Devices Inc · Class I
- THALES 3D MR SCANNER — L A P GMBH LASER APPLIKATIONEN · Class II
- QUASAR — Modus Medical Devices Inc · Class I
- Couchtop Base Varian Exact — 3C-Medical Intelligence GmbH · Class I
- Standard Imaging MIMI Phantom — STANDARD IMAGING, INC. · Class I
- Calibration Cube and Levelling Plate — Vision RT Ltd. · Class I
- QUASAR — Modus Medical Devices Inc · Class I
- QUASAR — Modus Medical Devices Inc · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4056481PatientMask38 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 63bbc051-6d57-4ce2-be1e-75938f7335e5 61 fields · synced Jun 20, 2026
- FDA UDI 785b9d49-020d-4306-997b-261112727454 35 fields · synced May 29, 2026