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CT Contrast Injection Device
EUDAMEDClass IIb (EU MDR)
Ref 0306Model Ascend A;Ascend A1;Ascend A2;Ascend A3
Identity
- Trade Name
- CT Contrast Injection Device EUDAMED
- Model / Reference
- Ascend A;Ascend A1;Ascend A2;Ascend A3 EUDAMED0306 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 69715532050418 EUDAMED
- Basic UDI-DI
- 697155320injectorA9 EUDAMED
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CT Contrast Injection Device by Nanjing Jusha Display Technology Co., Ltd. — Class IIb — 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 | 697155320injectorA9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nanjing Jusha Display Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027215
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED dd24ddba-5c50-4cc4-89a3-e0921861d410 61 fields · synced Jul 9, 2026