FDA Registration
Active
🇺🇸 United States
DORNIER MEDTECH AMERICA, INC.
Reg #: 1037955
·
FEI: 1037955
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DORNIER MEDTECH AMERICA, INC.
- Registration Number
- 1037955
- FEI Number
- 1037955
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1155 ROBERTS BLVD.
- City
- KENNESAW
- State
- GA
- ZIP
- 30144
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222162
Owner / Operator
- Firm Name
- Dornier MedTech America, Inc.
- Operator Number
- 1037955
- Address
- 1155 ROBERTS BLVD., Suite 100
- City
- Kennesaw
- State
- GA
- Postal Code
- 30144
- Country
- US
- Correspondent
- John - Hoffer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2022-11-21 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198