Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026572570

FEI Number

3026572570

Entity Name

TRUEPILL NY LLC

City/State/Country

Brooklyn, NY, US

Establishment Address

850 3rd Ave Suite 404, Brooklyn, NY 11232, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Truepill NY LLC (Owner Number: 10087232)

Owner / Operator Contact Address

850 3rd Ave Suite 404, Brooklyn, NY 11232, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191833

PMA Number

N/A

All Registered Proprietary Names

Truepill NY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QII	Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use	Clinical Chemistry	Class 2	862.1355	2023-01-31

Official Correspondent

Samantha Gabbard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Truepill NY LLC

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 3026572570. Last updated year: 2026. Please use registration number 3026572570 when referencing this establishment in official correspondence.