FDA Registration
Active
🇺🇸 United States
Molnlycke Manufacturing US, LLC
Reg #: 1225263
·
FEI: 3000719717
·
Expires 2026
Products
5
Proprietary Names
10
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- Molnlycke Manufacturing US, LLC
- Registration Number
- 1225263
- FEI Number
- 3000719717
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11 Twin Rivers Drive
- City
- Wiscasset
- State
- ME
- ZIP
- 04578
- Country
- US
Owner / Operator
- Firm Name
- MOLNLYCKE HEALTH CARE US LLC
- Operator Number
- 8030877
- Address
- 5445 Triangle Parkway, Suite 400
- City
- Peachtree Corners
- State
- GA
- Postal Code
- 30092
- Country
- US
- Correspondent
- Yannick Spenninck
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2009-02-06 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2021-08-30 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2016-12-20 |
| Lift, Patient, Ac-Powered | FNG | Class 2 | General Hospital | No | 2021-08-30 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2016-12-20 |
Proprietary Names
Dermafit
Tubipad
Tubigrip
Setopress
Tubifast
Elset
Static Air Heel Protector
Z-Flex Heel Boot
Z-Flo Fluidized Positioner
Tortoise Turning and Positioning System
Establishment Types
Manufacture Medical Device