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Cranial 4PI Headrest Inlay Standard 2Pcs
EUDAMEDFDA UDIClass I (EU MDR)
Ref 43446A
by Brainlab SE
Identity
- Trade Name
- Cranial 4PI Headrest Inlay Standard 2Pcs EUDAMEDCRANIAL 4PI HEADREST INLAY STANDARD 2PCS FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Cranial 4PI Headrest Inlays EUDAMED
- Model / Reference
- 43446A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144203 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481Cranial4PiHeadShJ4 EUDAMED
- 510(k) Number
- K202050 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
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
No
FDA UDI
Cranial 4PI Headrest Inlay Standard 2Pcs by Brainlab SE — 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 | 4056481Cranial4PiHeadShJ4 | 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 c577f43c-70f2-4c65-828d-0ba0b1c38f5b 61 fields · synced Jun 18, 2026
- FDA UDI 143091d6-a576-49ac-8847-612c3b3c205e 33 fields · synced May 30, 2026