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EmpowerCTA+ IV Pole
EUDAMEDFDA UDIClass I (EU MDR)
Ref 017528Model EmpowerCTA+®
Identity
- Trade Name
- EmpowerCTA+ IV Pole EUDAMEDIV Pole FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, stationary FDA UDI
- Model / Reference
- EmpowerCTA+® EUDAMED017528 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 017528 FDA UDI
- Primary DI / UDI-DI
- 37630039301980 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
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EmpowerCTA+ IV Pole by Bracco Injeneering SA — 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 | 76300393100000JM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bracco Injeneering SA
- EUDAMED SRN
- CH-MF-000019387
- Authorised Representative
- ACIST Europe BV NL-AR-000002151
Sources (2)
- EUDAMED 15677dba-5df6-4834-b271-afb91271b95e 61 fields · synced Jul 31, 2026
- FDA UDI 7efe93ac-b850-493e-8f1d-1c136039f202 34 fields · synced May 30, 2026