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Computed Tomographs
EUDAMEDClass IIb (EU MDR)
Ref N/AModel TurboTom 3, TurboTom 2400 PRO, TurboTom 3 S PLUS, TurboTom 5 PLUS, TurboTom 5 S PLUS, TurboTom 1 S PLUS, TurboTom 1 S PRO
Identity
- Device Name
- Computed Tomographs EUDAMED
- Model / Reference
- TurboTom 3, TurboTom 2400 PRO, TurboTom 3 S PLUS, TurboTom 5 PLUS, TurboTom 5 S PLUS, TurboTom 1 S PLUS, TurboTom 1 S PRO EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964319156 EUDAMED
- Basic UDI-DI
- 693896431900PA EUDAMED
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Computed Tomographs by Beijing Wandong 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 | 693896431900PA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing Wandong Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014174
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f9535624-9cde-4f01-97c9-137953432146 61 fields · synced Jun 18, 2026
- EUDAMED f9535624-9cde-4f01-97c9-137953432146-1 61 fields · synced Jun 10, 2026