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MR Contrast Delivery Systems SONIC SHOT 7
EUDAMEDClass IIb (EU MDR)
Ref SS70111
Identity
- Trade Name
- MR Contrast Delivery Systems SONIC SHOT 7 EUDAMED
- Device Name
- MR Contrast Delivery Systems SONIC SHOT 7 EUDAMED
- Model / Reference
- SS70111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560138482100 EUDAMED
- Basic UDI-DI
- B-04560138482100 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
MR Contrast Delivery Systems SONIC SHOT 7 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-04560138482100 | 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 89a17712-b5b8-4a6f-bfa2-b87128873ced 61 fields · synced Jun 18, 2026