Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012164459

FEI Number

3012164459

Entity Name

ZYWIE, INC.

City/State/Country

Johns Creek, GA, US

Establishment Address

12000 Findley Road, Suite 360, Johns Creek, GA 30097, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zywie, Inc. (Owner Number: 10050380)

Owner / Operator Contact Address

12000 Findley Road, Suite 360, Johns Creek, GA 30097, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2015-11-10

Official Correspondent

Latha Ganeshan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zywie, Inc.

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 3012164459. Last updated year: 2026. Please use registration number 3012164459 when referencing this establishment in official correspondence.