FDA Registration
Active
🇺🇸 United States
Describe
Reg #: 3013840437
·
FEI: 3013840437
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Merz North America, Inc.
- Registration Number
- 3013840437
- FEI Number
- 3013840437
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 13900 W. Grandview Parkway
- City
- Sturtevant
- State
- WI
- ZIP
- 53177
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172689
Owner / Operator
- Firm Name
- Merz North America, Inc.
- Operator Number
- 9043404
- Address
- 6501 Six Forks Road
- City
- Raleigh
- State
- NC
- Postal Code
- 27615
- Country
- US
- Correspondent
- Bonnie Safyurtlu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transparent Patch For Use In Treatment Of Tattoos | PKO | Class 2 | General, Plastic Surgery | No | 2020-09-23 |
Proprietary Names
Describe
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198