Identity
- Device Name
- X-ray computed Tomography System EUDAMED
- Model / Reference
- ANATOM S400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950743802123 EUDAMED
- Basic UDI-DI
- B-06950743802123 EUDAMED
- EMDN Code
- Z11030605 COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS EUDAMED
Classification
- Device Class
- Class IIb 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
X-ray computed Tomography System 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-06950743802123 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
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 (1)
- EUDAMED 82e51331-4e99-4e41-95e5-462b60ff14cb 61 fields · synced Jun 18, 2026