Identity
- Trade Name
- Docking station EUDAMEDPersonal Kinetigraph (PKG) FDA UDI
- Generic Name
- Neuromuscular motion disorder ambulatory recorder/analyser FDA UDI
- Device Name
- The Parkinsons KinetiGraph (PKG) System EUDAMEDThe PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. FDA UDI
- Model / Reference
- 2001-CHG-DOC EUDAMED2001-CHG-DOC-US FDA UDI
- Description
- The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09369998308569 EUDAMEDFDA UDI
- Basic UDI-DI
- 93590110GKC20XXEH EUDAMED
- Direct Marketing DI
- 09369998308569 EUDAMED
- EMDN Code
- Z12062599 KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER EUDAMED
- GMDN Term
- Neuromuscular motion disorder ambulatory recorder/analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Docking station by Gkc Manufacturing Pty Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 93590110GKC20XXEH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GKC Manufacturing Pty. Ltd.
- EUDAMED SRN
- AU-MF-000021150
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 6c8b5781-1378-4904-97e5-a1da5e1db2ad 61 fields · synced Jun 19, 2026
- FDA UDI 2004cb54-b444-4410-8dcc-b97fa569b9d3 33 fields · synced May 30, 2026