FDA Registration
Active
🇺🇸 United States
Marizyme, Inc.
Reg #: 3011421726
·
FEI: 3011421726
·
Expires 2026
Products
2
Proprietary Names
1
Establishment Types
2
Classifications
2
Registration Details
- Registration Name
- Marizyme, Inc.
- Registration Number
- 3011421726
- FEI Number
- 3011421726
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1645 Palm Beach Lakes Blvd Ste 1200
- City
- West Palm Bch
- State
- FL
- ZIP
- 33401
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240925
Owner / Operator
- Firm Name
- Marizyme, Inc.
- Operator Number
- 10081557
- Address
- 1645 Palm Beach Lakes Blvd, Suite 1200
- City
- West Palm Beach
- State
- FL
- Postal Code
- 33401
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries | QEJ | Class 2 | Gastroenterology, Urology | No | 2024-05-14 |
| Set, Perfusion, Kidney, Disposable | KDL | Class 2 | Gastroenterology, Urology | No | 2021-04-23 |
Proprietary Names
DuraGraft
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only