FDA Registration
Active
🇩🇪 Germany
ENDERS COLSMAN AG
Reg #: 3016218280
·
FEI: 3016218280
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ENDERS COLSMAN AG
- Registration Number
- 3016218280
- FEI Number
- 3016218280
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Brauck 1, Iserlohn HRB 5661
- City
- Werdohl North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K041096
Owner / Operator
- Firm Name
- Enders Colsman AG
- Operator Number
- 10061926
- Address
- Brauck 1
- City
- Werdohl
- State
- North Rhine-Westphalia
- Postal Code
- 58791
- Country
- DE
- Correspondent
- Alexander Zuchowski
US Agent
- Business Name
- Simcon International LLC
- Contact Name
- Rosanna Lee
- Address
- 1200 Townline Road
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
- [email protected]
- Phone
- 847 9492290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2019-12-03 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)