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Integrated Control Module
EUDAMEDFDA UDIClass I (EU MDR)
Ref 535-1766Model 555-1765, 555-1766. 535-1765. 535-1766
by Stille AB
Identity
- Trade Name
- Integrated Control Module EUDAMEDimagiQ FDA UDI
- Generic Name
- Fluoroscopy/angiography table, powered FDA UDI
- Device Name
- Integrated Control Module EUDAMEDControl module, US version, a unit with selected hand control functions and pan handle function built into one unit, side rail mounted. Accessory for imagiQ2 operation table FDA UDI
- Model / Reference
- 555-1765, 555-1766. 535-1765. 535-1766 EUDAMED535-1766 EUDAMEDControl module FDA UDI
- Description
- Control module, US version, a unit with selected hand control functions and pan handle function built into one unit, side rail mounted. Accessory for imagiQ2 operation table FDA UDI
Identifiers
- Catalog Number
- 535-1766 FDA UDI
- Primary DI / UDI-DI
- 07332339233617 EUDAMEDFDA UDI
- Basic UDI-DI
- 73323395008PK EUDAMED
- Direct Marketing DI
- 07332339233617 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
Integrated Control Module 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 | 73323395008PK | 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 01b137d0-e1fe-4d80-baf4-fe6ba63e67a3 61 fields · synced Jul 11, 2026
- FDA UDI 2ee18ee4-0f60-4263-a0e5-6c06d5137346 35 fields · synced May 30, 2026