Marizyme, Inc.

FDA Device Registration & Listing · West Palm Bch, FL, US · Registration 3011421726

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
3011421726
FEI Number
3011421726
Entity Name
Marizyme, Inc.
City/State/Country
West Palm Bch, FL, US
Establishment Address
1645 Palm Beach Lakes Blvd Ste 1200, West Palm Bch, FL 33401, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Marizyme, Inc. (Owner Number: 10081557)
Owner / Operator Contact Address
1645 Palm Beach Lakes Blvd, Suite 1200, West Palm Beach, FL 33401, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DuraGraft DuraGraft

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QEJ Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries Gastroenterology, Urology Class 2 876.4100 2024-05-14
KDL Set, Perfusion, Kidney, Disposable Gastroenterology, Urology Class 2 876.5880 2021-04-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Marizyme, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011421726. Last updated year: 2026. Please use registration number 3011421726 when referencing this establishment in official correspondence.
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