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Infivision
EUDAMEDClass IIa (EU MDR)
Ref 104002018Model Infivision EA300Ref 104002011Ref 104002017Ref 101001001Model Infivision ET1000Ref 104002013Ref 104003010Model Infivision EA400Ref 104003003Ref 104003005Ref 104003013Ref 104003015Ref 104003009Ref 104003002Ref 104003008
Identity
- Trade Name
- Infivision EUDAMED
- Device Name
- Electrode Belt EUDAMEDElectrical Impedance Tomography System EUDAMEDSingle-Use Electrode Belt EUDAMED
- Model / Reference
- Infivision EA300 EUDAMED104002018 EUDAMED104002011 EUDAMED104002017 EUDAMEDInfivision ET1000 EUDAMED101001001 EUDAMED104002013 EUDAMEDInfivision EA400 EUDAMED104003010 EUDAMED104003003 EUDAMED104003005 EUDAMED104003013 EUDAMED104003015 EUDAMED104003009 EUDAMED104003002 EUDAMED104003008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974419900111 EUDAMED06974419900142 EUDAMED06974419900128 EUDAMED06974419900005 EUDAMED06974419900166 EUDAMED06974419900517 EUDAMED06974419900395 EUDAMED06974419900418 EUDAMED06974419900487 EUDAMED06974419900463 EUDAMED06974419900456 EUDAMED06974419900388 EUDAMED06974419900449 EUDAMED
- Basic UDI-DI
- 697441990CHNBJYYEITA3006N EUDAMED697441990CHNBJYYEIT10002W EUDAMED697441990CHNBJYYEITA4006T EUDAMED
- Direct Marketing DI
- 06974419900005 EUDAMED
- EMDN Code
- Z12062404 ELECTRODERMAL SIGNAL BIOFEEDBACK SYSTEMS EUDAMEDZ11010801 TOMOTHERAPY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Infivision by Infivision Medical Imaging Technology Co., Ltd. — Class IIa — 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 | 697441990CHNBJYYEITA3006N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Infivision Medical Imaging Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000004093
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (13)
- EUDAMED dbf7e0f8-cff5-4be9-ad37-b7dc3f56f904 61 fields · synced Jul 25, 2026
- EUDAMED 6b35b071-492b-4e44-a16b-1ce68d9774aa 61 fields · synced May 18, 2026
- EUDAMED 826609fa-05f0-48fe-a0e8-a327079e41a9 61 fields · synced May 18, 2026
- EUDAMED 6ba96aac-10e5-45fc-8ff2-45b2a5563eda 61 fields · synced May 18, 2026
- EUDAMED f13effa6-e814-4322-8400-b372894aede0 61 fields · synced May 19, 2026
- EUDAMED f83c2eec-e272-4efb-b940-54f909a231c1 61 fields · synced Jun 20, 2026
- EUDAMED 5e2e8d54-8f6d-4246-bc88-dd817be8d519 61 fields · synced Jul 11, 2026
- EUDAMED f618de15-8d41-475e-abf2-c46d587f9832 61 fields · synced Jul 12, 2026
- EUDAMED 57a8a239-b85b-4932-98c0-a32b9dbb48d1 61 fields · synced Jul 12, 2026
- EUDAMED 6c720380-c1bf-44bd-8b81-844bf3850693 61 fields · synced Jul 12, 2026
- EUDAMED 76e5a8e9-5306-4269-80d1-1311f54d78bf 61 fields · synced Jul 19, 2026
- EUDAMED a87f915d-6ea1-47c9-ba5c-212667647c07 61 fields · synced Jul 23, 2026
- EUDAMED 2a10921b-fde8-4067-8a81-9b428eb18276 61 fields · synced Jul 25, 2026