Eu Mdr
Eu Md Class 2a
On The Market
🇺🇸 United States
PKG System
Devices (same UDI-DI)
3
Certificates
0
Countries
5
Notified Bodies
0
Basic Information
- Primary DI
- 09359011000006
- Basic UDI-DI Code
- 93590110GKC20XXEH
- Reference
- PKG System
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- GKC Manufacturing Pty. Ltd.
Additional Description
The PKG System comprises of a small, wrist-worn activity monitor (PKG Watch) that continuously records a person’s kinematics over several days. This data is analysed by proprietary algorithms that transform raw kinematic data into actionable information in the form of a diagnostic report (PKG Report). PKG Report can be used to assess the extent and severity of movement disorder symptoms, and how they vary throughout the day, and from day to day.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12062599 | KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER |
Available In Countries
🇩🇪 Germany
🇪🇸 Spain
🇫🇷 France
🇳🇱 Netherlands
🇸🇪 Sweden
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The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.
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