Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019843904

FEI Number

3019843904

Entity Name

OMEZA, LLC

City/State/Country

Sarasota, FL, US

Establishment Address

1610 Northgate Blvd, Sarasota, FL 34234, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Omeza, LLC (Owner Number: 10082892)

Owner / Operator Contact Address

1610 Northgate Blvd, Sarasota, FL 34234, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211972

PMA Number

N/A

All Registered Proprietary Names

OMEZA Complete Matrix OCM Trademark

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-10-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Omeza, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

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3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3017552041	SHANGHAI MEBO LIFE SCIENCE & TECHNOLOGY CO., LTD.	Pudong District Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019843904. Last updated year: 2026. Please use registration number 3019843904 when referencing this establishment in official correspondence.