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CT Contrast Delivery Systems SmartShot alpha
EUDAMEDClass IIb (EU MDR)
Ref Many
Identity
- Trade Name
- CT Contrast Delivery Systems SmartShot alpha EUDAMED
- Device Name
- CT Contrast Delivery Systems SmartShot alpha EUDAMED
- Model / Reference
- Many EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560138482001 EUDAMED
- Basic UDI-DI
- B-04560138482001 EUDAMED
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium 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 Contrast Delivery Systems SmartShot alpha by Nemoto Kyorindo Co., Ltd. — 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-04560138482001 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nemoto Kyorindo Co., Ltd.
- EUDAMED SRN
- JP-MF-000004827
- Authorised Representative
- Medicor International NV/SA BE-AR-000003308
Sources (1)
- EUDAMED 2d2af8e8-e9c2-4b5c-879e-91fa06c90cbf 61 fields · synced Jul 22, 2026