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Vital Signs Head Positioner
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8000HDP-CEModel Vital Signs Head Positioner
by SunMed
Identity
- Trade Name
- Vital Signs Head Positioner EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Freestanding headrest, reusable FDA UDI
- Device Name
- Vital Signs™ Head Positioner FDA UDI
- Model / Reference
- Vital Signs Head Positioner EUDAMED8000HDP-CE EUDAMEDFDA UDI
- Description
- Vital Signs™ Head Positioner FDA UDI
Identifiers
- Catalog Number
- 8000HDP-CE FDA UDI
- Primary DI / UDI-DI
- 10889483642351 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889483TF20043aHeadPosEW EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Freestanding headrest, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vital Signs Head Positioner by SunMed — 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 | 0889483TF20043aHeadPosEW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SunMed
- EUDAMED SRN
- US-MF-000009164
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 27763d5b-bf91-4c51-b1aa-e9153d0c7e3f 61 fields · synced Jul 21, 2026
- FDA UDI 8bbb38b5-7ade-46ea-bda2-a92220095b14 35 fields · synced May 29, 2026