Identity
- Device Name
- Ziostation2 Plus EUDAMED
- Model / Reference
- N/A EUDAMED04571320222022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MDD_ZS2PlusKR EUDAMED04571320222022 EUDAMED
- Basic UDI-DI
- B-MDD_ZS2PlusKR EUDAMED457132022A009C EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMEDZ129092 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMEDSoftware EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Ziostation2 Plus is a Class IIa active medical device, classified under nomenclature code Z110603, designed for measuring and monitoring physiological parameters. It functions as a diagnostic tool, providing real-time data collection and analysis for clinical use in various healthcare settings.
This device is non-sterile, non-reusable, and non-implantable, intended for single-use applications. It is authorized under FDA 510K, MDD, and MDR regulations, with a Basic UDI of B-MDD_ZS2PlusKR. Supplied as a standalone unit, it requires appropriate storage conditions to maintain functionality and is regulated as a legacy device under current medical technology frameworks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-MDD_ZS2PlusKR | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K070205 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K200315 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K181892 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-MDD_ZS2PlusKR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ziosoft, Inc.
- EUDAMED SRN
- JP-MF-000025176
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 8d54348e-1aa7-44b5-ade9-db8293e212f5 61 fields · synced Sep 18, 2026
- EUDAMED f6534f2c-3ea6-4772-85d3-455020ab324a 61 fields · synced Jul 9, 2026
- FDA 510(k) K070205 1 fields · synced May 18, 2026