Identity
- Trade Name
- InferOperate® EUDAMED
- Device Name
- InferOperate Suite EUDAMED
- Model / Reference
- InferOperate Suite EUDAMED30458894 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974692711190 EUDAMED
- Basic UDI-DI
- 697469271119PT EUDAMED
- Direct Marketing DI
- 06974692711190 EUDAMED
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
InferOperate® by Infervision 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 | 697469271119PT | Class IIb | 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 (1)
- EUDAMED 915fb71b-06b1-4cd1-89ea-e024e8637111 61 fields · synced May 23, 2026