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Sign in to claim this brandGKC MANUFACTURING PTY LTD
Australia·AU-MF-000021150
Last updated September 17, 2026
Information
- Country
- Australia
- Address
- 31, Queen Street, Melbourne, Australia
- Website
- pkgcare.com/
- —
- —
- [email protected]
- Phone
- 1 (888) 970 8714
- PRRC Contact
- Dane Mellan
- EUDAMED SRN
- AU-MF-000021150
- FDA FEI Number
- 3011196543
- DUNS Number
- 742903370
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Personal KinetiGraph (PKG) | 2023-LOG-G3 | FDA UDI | N/A | Active |
| Personal KinetiGraph (PKG) | 2022-CHG-DOC-V1.2 | FDA UDI | N/A | Active |
| Personal Kinetigraph (PKG) | GKC-2000 | FDA UDI | N/A | Active |
| Personal Kinetigraph (PKG) | 2000-LOG-004 | FDA UDI | N/A | Active |
| Personal KinetiGraph (PKG) | 2022-CHG-DOC-UNI | FDA UDI | N/A | Active |
| Personal KinetiGraph (PKG) | 2022-CHG-DOC-004 | FDA UDI | N/A | Active |
| Personal Kinetigraph (PKG) | GKC-2009 | FDA UDI | N/A | Active |
| Personal Kinetigraph (PKG) System | K161717 | FDA 510(k) | Class II | Active |
| Personal Kinetigraph (pkg) System | K140086 | FDA 510(k) | Class II | Active |
| Personal Kinetigraph (PKG) System Gen 2 Plus | K211887 | FDA 510(k) | Class II | Active |
| PKG System | 2022-CHG-DOC-006 | EUDAMED | Class IIa | Active |
| Docking station | 2001-CHG-DOC | EUDAMEDFDA UDI | Class IIa | Active |
Related Companies
Authorised Representatives
- CEpartner4U NL
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