Identity
- Trade Name
- CT Expres 4D EUDAMED
- Device Name
- CT Expres 4D EUDAMED
- Model / Reference
- 650208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 47630039301932 EUDAMED
- Basic UDI-DI
- B-47630039301932 EUDAMED
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CT Expres 4D by Bracco Injeneering SA — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-47630039301932 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bracco Injeneering SA
- EUDAMED SRN
- CH-MF-000019387
- Authorised Representative
- ACIST Europe BV NL-AR-000002151
Sources (1)
- EUDAMED d7eecd47-fdd6-48b4-9134-df604bb2a449 61 fields · synced Jun 18, 2026