Cranial 4PI Stereotactic Mask 3.2mm (5Pcs)
EUDAMEDFDA UDIClass I (EU MDR)
by Brainlab SE
Identity
- Trade Name
- Cranial 4PI Stereotactic Mask 3.2mm (5Pcs) EUDAMEDCRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.) FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Cranial 4Pi Masks EUDAMED
- Model / Reference
- 43454 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481145354 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481Cranial4PiMasksEA EUDAMED
- 510(k) Number
- K243142 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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Multi-modality therapeutic radiation phantom, test object
Cranial 4PI Stereotactic Mask 3.2mm (5Pcs) by Brainlab SE — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4056481Cranial4PiMasksEA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED d6acdc33-a588-4321-b7a8-5d969aff054b 61 fields · synced Jul 26, 2026
- FDA UDI 17dacbc2-1928-4aa2-b540-d80bd47a8c0f 33 fields · synced May 30, 2026