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Side rail EU
EUDAMEDFDA UDIClass I (EU MDR)
Ref 535-1721Model 535-1720, 535-1721, 535-1723, 535-1724, 535-1725, 535-1729
by Stille AB
Identity
- Trade Name
- Side rail EU EUDAMEDimagiQ FDA UDI
- Generic Name
- Medical device rail FDA UDI
- Device Name
- Side rail EUDAMEDSide rail EU model (80,5cm) Accessory for imagiQ operating table FDA UDI
- Model / Reference
- 535-1720, 535-1721, 535-1723, 535-1724, 535-1725, 535-1729 EUDAMED535-1721 EUDAMEDSide rail FDA UDI
- Description
- Side rail EU model (80,5cm) Accessory for imagiQ operating table FDA UDI
Identifiers
- Catalog Number
- 535-1721 FDA UDI
- Primary DI / UDI-DI
- 07332339220594 EUDAMEDFDA UDI
- Basic UDI-DI
- 73323395001P5 EUDAMED
- Direct Marketing DI
- 07332339220594 EUDAMED
- FDA Product Code
- GDC FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Medical device rail 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
Side rail EU 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 | 73323395001P5 | 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 f6cdc86f-e667-4114-839b-ed4d7bb429e7 61 fields · synced Jun 20, 2026
- FDA UDI 6794d033-d1a9-456f-8b50-77c74dc59d31 35 fields · synced May 30, 2026