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X-ray computed Tomography System
EUDAMEDClass IIb (EU MDR)
Ref ANATOM 64 ClarityModel ANATOM 64 Clarity Ref ANATOM 128Ref ANATOM S800Ref ANATOM 64 FitModel ANATOM 64 FitRef ANATOM 32 FitModel ANATOM 32 Fit Ref ANATOM 16HD Model ANATOM 16HDRef ANATOM 64 PrecisionModel ANATOM 64 PrecisionRef ANATOM C200Model ANATOM C200/C201/C210Ref ANATOM C201
Identity
- Device Name
- X-ray computed Tomography System EUDAMED
- Model / Reference
- ANATOM 64 Clarity EUDAMEDANATOM 128 EUDAMEDANATOM S800 EUDAMEDANATOM 64 Fit EUDAMEDANATOM 64 Fit EUDAMEDANATOM 32 Fit EUDAMEDANATOM 16HD EUDAMEDANATOM 64 Precision EUDAMEDANATOM 64 Precision EUDAMEDANATOM C200/C201/C210 EUDAMEDANATOM C200 EUDAMEDANATOM C201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950743802062 EUDAMED06950743802079 EUDAMED06950743802130 EUDAMED06950743802116 EUDAMED06950743802109 EUDAMED06950743802048 EUDAMED06950743802055 EUDAMED06950743802147 EUDAMED06950743802154 EUDAMED
- Basic UDI-DI
- B-06950743802062 EUDAMEDB-06950743802079 EUDAMEDB-06950743802130 EUDAMEDB-06950743802116 EUDAMEDB-06950743802109 EUDAMEDB-06950743802048 EUDAMEDB-06950743802055 EUDAMED695074380200H4 EUDAMED
- Direct Marketing DI
- 06950743802147 EUDAMED06950743802154 EUDAMED
- EMDN Code
- Z11030603 COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS EUDAMEDZ11030605 COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS EUDAMEDZ11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS 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
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, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06950743802062 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06950743802062 | 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 (9)
- EUDAMED 6d858e2a-a723-4b64-a9bc-3b12b54c1a17 61 fields · synced Aug 4, 2026
- EUDAMED c5289640-3f93-4bcf-ac4c-4125f200c7bc 61 fields · synced May 16, 2026
- EUDAMED d2de48ca-e6f5-477e-b30a-3aa257143bb1 61 fields · synced May 17, 2026
- EUDAMED e9e68bd4-825f-4ec8-be5e-5069b79aa737 61 fields · synced May 18, 2026
- EUDAMED f44a08a3-0ad7-4397-beb0-fb11c4dc3d7d 61 fields · synced May 18, 2026
- EUDAMED 5047f3dc-fd52-4946-8a89-c8a34419d25c 61 fields · synced May 18, 2026
- EUDAMED faecbf2c-8db4-4cc6-9cae-2ac7bb5021df 61 fields · synced May 18, 2026
- EUDAMED 22f47d6c-d3f9-47e4-a510-f3fc2d0a5fa3 61 fields · synced Jul 14, 2026
- EUDAMED 53ebcead-8b2b-4d93-b454-f2cfe9b97e71 61 fields · synced Jul 20, 2026