Identity
- Device Name
- CT Enhancement Injector EUDAMED
- Model / Reference
- ASA-200E EUDAMEDASA-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950743804028 EUDAMED06950743804042 EUDAMED
- Basic UDI-DI
- B-06950743804028 EUDAMEDB-06950743804042 EUDAMED
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania EUDAMEDItaly 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 Enhancement Injector by Shenzhen Anke High-Tech 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-06950743804028 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Anke High-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000016473
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 75bc480c-90b9-4115-b0cd-9b0c88cad5e8 61 fields · synced Oct 1, 2026
- EUDAMED 233714a4-ffce-41f7-a7c4-529664ffbc6c 61 fields · synced May 17, 2026