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InferOperate® Software
EUDAMEDClass I (EU MDR)
Ref 30192180Model InferOperate 3D, InferOperate Thorax 3D, InferOperate Liver 3D, InferOperate Urology 3D
Identity
- Trade Name
- InferOperate® Software EUDAMED
- Device Name
- InferOperate Software EUDAMED
- Model / Reference
- InferOperate 3D, InferOperate Thorax 3D, InferOperate Liver 3D, InferOperate Urology 3D EUDAMED30192180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974692710810 EUDAMED06974692710834 EUDAMED06974692710803 EUDAMED
- Basic UDI-DI
- 697469271083PX EUDAMED
- Direct Marketing DI
- 06974692710810 EUDAMED06974692710834 EUDAMED06974692710803 EUDAMED
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Category: Full-body CT system
InferOperate® Software by Infervision Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697469271083PX | Class I | Active |
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Manufacturer
- Manufacturer
- Infervision Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000026583
- Authorised Representative
- Infervision Europe GmbH DE-AR-000023562
Sources (3)
- EUDAMED 44935b0b-4863-4ce8-9e67-5ce56b9f5f4f 61 fields · synced Jul 31, 2026
- EUDAMED 559ae239-8d86-4e74-bed5-2d157e6efb44 61 fields · synced May 17, 2026
- EUDAMED 2211290c-9f4b-4f61-b446-e72224b999d8 61 fields · synced May 18, 2026