Identity
- Trade Name
- EmpowerCTA+ Floor Stand EUDAMEDFloor Stand FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, stationary FDA UDI
- Model / Reference
- 017410 EUDAMEDFDA UDIEmpowerCTA+® EUDAMED
Identifiers
- Catalog Number
- 017410 FDA UDI
- Primary DI / UDI-DI
- 37630039300693 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300393100000JM EUDAMED
- FDA Product Code
- DSB FDA UDIJAK FDA UDIIZQ FDA UDI
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
- GMDN Term
- CT contrast medium injection system, line-powered, stationary FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2770 FDA UDI892.1750 FDA UDI870.1650 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: CT contrast medium injection system, line-powered, stationary
Floor Stand by Bracco Injeneering — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bracco Injeneering
Sources (2)
- FDA UDI b24384fe-9764-435b-bb41-aa7dfa06c6fb 35 fields · synced Jul 14, 2026
- EUDAMED 5dd62bb1-e0cf-472b-a0fd-4be1e8f7d1bb 61 fields · synced Jul 14, 2026