GKC MANUFACTURING PTY LTD

FDA Device Registration & Listing · Melbourne Victoria, AU · Registration 3011196543

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011196543
FEI Number
3011196543
Entity Name
GKC MANUFACTURING PTY LTD
City/State/Country
Melbourne Victoria, AU
Establishment Address
Level 9, 31 Queen Street, Melbourne Victoria 3000, AU
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Empatica S.r.l. (Owner Number: 10047497)
Owner / Operator Contact Address
Via Stendhal, 36, Milan, IT-MI 20144, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161717
PMA Number
N/A

All Registered Proprietary Names

Personal KinetiGraph (PKG) System PKG Personal Kinetigraph System PKG

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GYD Transducer, Tremor Neurology Class 2 882.1950 2014-09-22
NXQ Reminder, Medication Physical Medicine Class 1 890.5050 2014-09-22
ISD Exerciser, Measuring Physical Medicine Class 2 890.5360 2014-09-22
ISD Exerciser, Measuring Physical Medicine Class 2 890.5360 2016-12-19
NXQ Reminder, Medication Physical Medicine Class 1 890.5050 2016-12-19
GYD Transducer, Tremor Neurology Class 2 882.1950 2016-12-19

Official Correspondent

Alberto Poli

US Agent Details

Matteo Lai Business: Empatica Inc. Email: ml@empatica.com Phone: (415) 5483860

Related Public Records

Same Entity

Empatica S.r.l.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011196543. Last updated year: 2026. Please use registration number 3011196543 when referencing this establishment in official correspondence.
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