Identity
- Trade Name
- Horseshoe Headrest FDA UDI
- Generic Name
- Freestanding headrest, reusable FDA UDI
- Device Name
- Horseshoe Headrest EUDAMEDHorseshoe Headrest Starter Kit, HFD 100 FDA UDI
- Model / Reference
- 116668-000 EUDAMEDFDA UDI
- Description
- Horseshoe Headrest Starter Kit, HFD 100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857534006837 EUDAMEDFDA UDI
- Basic UDI-DI
- 085753400600123EE EUDAMED
- FDA Product Code
- HBM FDA UDI
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Freestanding headrest, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 882.4440 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
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
MR Safe FDA UDI
Horseshoe Headrest by IMRIS Imaging, 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 | 085753400600123EE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IMRIS Imaging, Inc.
- EUDAMED SRN
- US-MF-000041458
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a136c332-eeb0-488d-aa65-823b0f4f6dae 61 fields · synced Jul 15, 2026
- FDA UDI f4b2133e-a26b-44f8-bef6-026d4629f764 33 fields · synced May 30, 2026