Identity
- Trade Name
- CT Expres Handle EUDAMED
- Model / Reference
- CT Expres Accessories EUDAMED640650 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17630039301306 EUDAMED
- Basic UDI-DI
- 76300393300000KF EUDAMED
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
CT Expres Handle by Bracco Injeneering SA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300393300000KF | Class I | 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 f2c7163d-bf98-48a1-8a59-be28e81bcf11 61 fields · synced Jul 9, 2026