Identity
- Trade Name
- Whitmyer EUDAMEDFDA UDI
- Generic Name
- Wheelchair/chair/stander headrest FDA UDI
- Device Name
- Whitmyer EUDAMEDThis basic wheelchair headrest is ideal for tilt or recline, accepts additional lateral and anterior supports, and is easily adjustable to adapt with clients as their needs change. FDA UDI
- Model / Reference
- Whitmyer EUDAMEDFDA UDI
- Description
- This basic wheelchair headrest is ideal for tilt or recline, accepts additional lateral and anterior supports, and is easily adjustable to adapt with clients as their needs change. FDA UDI
Identifiers
- Catalog Number
- E0955 FDA UDI
- Primary DI / UDI-DI
- 00016958050318 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958whitmyerD7 EUDAMED
- Direct Marketing DI
- 00016958050318 EUDAMED
- FDA Product Code
- IMS FDA UDI
- EMDN Code
- Y181899 SUPPORT SYSTEMS - OTHER EUDAMED
- GMDN Term
- Wheelchair/chair/stander headrest FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Whitmyer by Sunrise Medical (US) LLC — 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 | 0016958whitmyerD7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
- EUDAMED SRN
- US-MF-000007254
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (2)
- EUDAMED 82abfb2b-5260-43fe-8862-197ab942bfcf 61 fields · synced Jun 19, 2026
- FDA UDI 22295a08-60af-42cf-bac7-5831820aae03 34 fields · synced May 30, 2026