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Head rest fixed
EUDAMEDFDA UDIClass I (EU MDR)
Ref 535-1741Model 535-1741, 535-1742, 535-1745
by Stille AB
Identity
- Trade Name
- Head rest fixed EUDAMEDimagiQ FDA UDI
- Generic Name
- Fluoroscopy/angiography table, powered FDA UDI
- Device Name
- Head rest EUDAMEDHead rest fixed. Accessory for imagiQ2 operation table FDA UDI
- Model / Reference
- 535-1741, 535-1742, 535-1745 EUDAMED535-1741 EUDAMEDHead rest fixed FDA UDI
- Description
- Head rest fixed. Accessory for imagiQ2 operation table FDA UDI
Identifiers
- Catalog Number
- 535-1741 FDA UDI
- Primary DI / UDI-DI
- 07332339220709 EUDAMEDFDA UDI
- Basic UDI-DI
- 73323395003P9 EUDAMED
- Direct Marketing DI
- 07332339220709 EUDAMED
- FDA Product Code
- GDC FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Fluoroscopy/angiography table, powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Sweden 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
No
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
Head rest fixed by Stille AB — 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 | 73323395003P9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stille AB
- EUDAMED SRN
- SE-MF-000001228
Sources (2)
- EUDAMED 3711e26b-fc49-4e51-a503-4bac53ba63d8 61 fields · synced Jul 12, 2026
- FDA UDI 04ebb30b-1ad8-4a43-a60e-cfb23240edd8 35 fields · synced May 30, 2026