STOMAGIENICS, INC.

FDA Device Registration & Listing · Greenville, SC, US · Registration 3014016843

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
3014016843
FEI Number
3014016843
Entity Name
STOMAGIENICS, INC.
City/State/Country
Greenville, SC, US
Establishment Address
121 Industrial Blvd, Unit 4, Greenville, SC 29615, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Stomagienics, Inc. (Owner Number: 10055933)
Owner / Operator Contact Address
210 Austin Brook Street, Simpsonville, SC 29680, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Clinician Kit StomaGenie Sizing Template StomaGenie Clinician Kit StomaGenie Template

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PQE Ostomy Care Kit Gastroenterology, Urology Class 1 876.5900 2018-09-26
EXA Selector, Size, Ostomy Gastroenterology, Urology Class 1 876.5900 2018-09-26
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2017-10-19

Official Correspondent

Theresa Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Stomagienics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2012 Convatec Inc. 1
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014016843. Last updated year: 2026. Please use registration number 3014016843 when referencing this establishment in official correspondence.
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