Identity
- Trade Name
- CT Expres Patient Set Evo EUDAMED
- Device Name
- CT Expres Patient Set Evo EUDAMED
- Model / Reference
- 640647 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-640647Q9 EUDAMED
- Basic UDI-DI
- B-640647Q9 EUDAMED
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
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 Patient Set Evo by Bracco Injeneering SA — Class IIa — 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-640647Q9 | Class IIa | 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 6191a7a7-8475-4110-b741-38719c954bc0 61 fields · synced Jul 12, 2026