Identity
- Trade Name
- X-Ray Equipment for Computed Tomography EUDAMED
- Device Name
- X-ray equipment for computed tomography EUDAMED
- Model / Reference
- XHCT-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614965245 EUDAMED
- Basic UDI-DI
- 697061496030002QW EUDAMED
- Direct Marketing DI
- 06970614965245 EUDAMED
- EMDN Code
- Z11030603 COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 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
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 Equipment for Computed Tomography by Shinva Medical Instrument 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 | 697061496030002QW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shinva Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009856
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 536c3601-e8ff-44e8-87b3-e5aebfebbcb4 61 fields · synced Jun 18, 2026