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X-ray Computed Tomography System
EUDAMEDClass IIb (EU MDR)
Ref ANATOM C210Model ANATOM C200/C201/C210
Identity
- Device Name
- X-ray Computed Tomography System EUDAMED
- Model / Reference
- ANATOM C200/C201/C210 EUDAMEDANATOM C210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950743802161 EUDAMED
- Basic UDI-DI
- 695074380200H4 EUDAMED
- Direct Marketing DI
- 06950743802161 EUDAMED
- EMDN Code
- Z11030603 COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania 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
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 — 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 | 695074380200H4 | 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 (1)
- EUDAMED 0d9bd3e4-65d3-4a02-9402-cd043a96ee41 61 fields · synced Jun 18, 2026