Identity
- Trade Name
- Hyperfine Foam Head Pad FDA UDI
- Generic Name
- Radiological headrest FDA UDI
- Device Name
- Foam Head Pad EUDAMEDMemory foam cushion used as a support device to aid in the positioning of the patient’s head during an MRI procedure. FDA UDI
- Model / Reference
- 900-11021-00 EUDAMED810-11108-00 FDA UDI
- Description
- Memory foam cushion used as a support device to aid in the positioning of the patient’s head during an MRI procedure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850043319047 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850043319900110210026 EUDAMED
- FDA Product Code
- IWY FDA UDI
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
- GMDN Term
- Radiological headrest FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1920 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Foam Head Pad by Hyperfine, Inc. — 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 | 0850043319900110210026 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hyperfine, Inc.
- EUDAMED SRN
- US-MF-000029806
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f532a8cb-e0eb-44da-92ed-3e0aa346fee5 61 fields · synced Jun 19, 2026
- FDA UDI 63d7722e-79dc-4816-ab2e-6bfa966fe391 33 fields · synced May 30, 2026