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JiveX
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref JiveX 5.3.0.40+510(k) K181964Ref JiveX
Identity
- Trade Name
- JiveX EUDAMED
- Device Name
- JiveX EUDAMED
- Model / Reference
- JiveX 5.3.0.40+ EUDAMEDJiveX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260632470046 EUDAMED
- Basic UDI-DI
- 426063247JiveXMV EUDAMEDB-04260632470046 EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED-1192 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
JiveX by VISUS Health IT GmbH — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181964 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K200703 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 426063247JiveXMV | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 426063247JiveXMV | Class IIa | Active |
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Manufacturer
- Manufacturer
- VISUS Health IT GmbH
- EUDAMED SRN
- DE-MF-000005585
Sources (3)
- EUDAMED 23c8ac44-5dc8-46b5-b11d-ab3c045130c2 85 fields · synced Jul 11, 2026
- EUDAMED d962f8a3-5340-494a-8e9f-69a88dce969b 61 fields · synced May 17, 2026
- FDA 510(k) K181964 1 fields · synced May 18, 2026