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Portrait™ Intracranial, Head and Neck
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-4552Model Head and Neck
by Qfix
Identity
- Trade Name
- Portrait™ Intracranial, Head and Neck FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- Portrait Intracranial Head and Neck Device FDA UDI
- Model / Reference
- RT-4552 EUDAMEDFDA UDIHead and Neck EUDAMED
- Description
- Portrait Intracranial Head and Neck Device FDA UDI
Identifiers
- Catalog Number
- RT-4552 FDA UDI
- Primary DI / UDI-DI
- 10841962109335 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621HEADNECKX4 EUDAMED
- FDA Product Code
- JAI FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Patient positioner base plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5770 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient positioner base plate
Portrait™ Intracranial, Head and Neck by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Patient positioner base plate.
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- Arthrex TRIMANO quick adapter — Maquet, Inc. · Class I
- Uni-frame® Baseplate — Medtec LLC · Class II
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 65ae2411-abca-4937-8999-5ced133f1da2 35 fields · synced Jun 18, 2026
- EUDAMED ec8b17dc-5446-40c8-9063-e844bc13600c 61 fields · synced Jun 18, 2026