Identity
- Trade Name
- PKG System EUDAMED
- Device Name
- The Parkinsons KinetiGraph (PKG) System EUDAMED
- Model / Reference
- 2022-CHG-DOC-006 EUDAMEDPKG System EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09359011000334 EUDAMED09359011000006 EUDAMED
- Basic UDI-DI
- 93590110GKC20XXEH EUDAMED
- Direct Marketing DI
- 09359011000006 EUDAMED
- EMDN Code
- Z12062599 KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDSweden 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
PKG System by Gkc Manufacturing Pty 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 | 93590110GKC20XXEH | Class IIa | Active |
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Manufacturer
- Manufacturer
- GKC Manufacturing Pty. Ltd.
- EUDAMED SRN
- AU-MF-000021150
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED d1feef11-06e4-4190-beca-f8dcaaa19ec0 61 fields · synced Aug 1, 2026
- EUDAMED 6911891c-9469-4435-863e-4c4975217fc8 61 fields · synced May 18, 2026