Identity
- Trade Name
- ANKE EUDAMED
- Device Name
- X-ray Computed Tomography System EUDAMED
- Model / Reference
- ANATOM A200 EUDAMEDANATOM P428 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973740220516 EUDAMED06973740220714 EUDAMED
- Basic UDI-DI
- 697374022CT23 EUDAMED
- EMDN Code
- Z11030603 COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS EUDAMEDZ11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Anke by Nanjing Anke Medical 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 | 697374022CT23 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nanjing Anke Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018623
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b5b8fe7d-6ea3-40ca-baba-f421993bd08e 61 fields · synced Jul 30, 2026
- EUDAMED 13d48c48-6aa5-4670-be85-f7706bdd5b28 61 fields · synced May 18, 2026