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Neuro Head Holder
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 8002046Model Surgical and Diagnostic Devices
by Qfix
Identity
- Trade Name
- Neuro Head Holder FDA UDI
- Generic Name
- Radiological headrest FDA UDI
- Device Name
- Neuro Head Holder FDA UDI
- Model / Reference
- 8002046 EUDAMEDFDA UDISurgical and Diagnostic Devices EUDAMED
- Description
- Neuro Head Holder FDA UDI
Identifiers
- Catalog Number
- 8002046 FDA UDI
- Primary DI / UDI-DI
- 10841962111192 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621SURGDXAA EUDAMED
- FDA Product Code
- IWY FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological headrest FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1920 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological headrest
Neuro Head Holder by Qfix — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological headrest.
- Positioning Cushion — Medtec LLC · Class II
- Headrest — Medtec LLC · Class II
- Neck & Brachial Plexus SatPad™ Set — Sat Pad Inc. · Class II
- Headrest — Medtec LLC · Class II
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class I
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
- Shim — Medtec LLC · Class II
- Positioning Cushion — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI 2ccf9ee1-cf36-4a78-b0f5-f967c8587c0a 35 fields · synced Jul 10, 2026
- EUDAMED bfccb83b-2db0-4a13-8791-852bd9bf00e5 61 fields · synced Jul 10, 2026