FDA Registration
Active
🇩🇰 Denmark
MERMAID MEDICAL A/S
Reg #: 3007146453
·
FEI: 3007146453
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- MERMAID MEDICAL A/S
- Registration Number
- 3007146453
- FEI Number
- 3007146453
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Frydensbergvej 25
- City
- Stenloese Hovedstaden
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K160747
Owner / Operator
- Firm Name
- Mermaid Medical
- Operator Number
- 10045264
- Address
- 8033 Cooper Creek Blvd, Unit 106
- City
- University Park
- State
- FL
- Postal Code
- 34201
- Country
- US
- Correspondent
- Matthew Genzman
US Agent
- Business Name
- Mermaid Medical
- Contact Name
- Matthew Genzman
- Address
- 8033 Cooper Creek Blvd
- City
- University Park
- State
- FL
- ZIP
- 34201
- Country
- US
- [email protected]
- Phone
- 941 8672129
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Short-Term Intravascular Filter Catheter | PNS | Class 2 | Cardiovascular | No | 2019-11-27 |
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 2013-11-21 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2013-11-29 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2019-11-27 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2026-01-05 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2026-01-05 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2026-01-05 |
Proprietary Names
Angel® Catheter Accessory Kit
Angel® Catheter
M-Biopsy
M-Drain Percutaneous Introducer System
Angel® Catheter Accesory Kit
M- Drain Catheter
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device