Facility

GKC MANUFACTURING PTY LTD

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011196543
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	Level 9, 31 Queen Street Melbourne Victoria, AU 3000
Registration status	Active · expires 2026
Parent company	Empatica S.r.l. (owner-operator 10047497)
Brand names	Personal KinetiGraph (PKG) System; PKG

Activity by year

Recalls (1)

Devices registered here (3)

Reminder, Medication
Product code NXQ (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.5050
Transducer, Tremor
Product code GYD (opens in a new tab) · Class II · Neurology · 21 CFR 882.1950
Exerciser, Measuring
Product code ISD (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5360

Recalls & enforcement

Class IIOngoing2023-07-13
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

All facilities operated by Empatica S.r.l.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “GKC MANUFACTURING PTY LTD (FEI 3011196543) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011196543-gkc-manufacturing-pty-ltd/

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