FDA Registration
Active
🇩🇪 Germany
K LINE EUROPE GMBH
Reg #: 3015129327
·
FEI: 3015129327
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- K LINE EUROPE GMBH
- Registration Number
- 3015129327
- FEI Number
- 3015129327
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SEGRO Park Dusseldorf-Sud, Section 203 K, Bonner Strasse 203-393
- City
- Dusseldorf-Benrath North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K200908
Owner / Operator
- Firm Name
- K LINE EUROPE GMBH
- Operator Number
- 10079939
- Address
- Bonner Strasse 203-393, SEGRO Park Dusseldorf-Sud, Section 203 K
- City
- Dusseldorf-Benrath
- State
- North Rhine-Westphalia
- Postal Code
- 40589
- Country
- DE
- Correspondent
- Sherif Kandil
US Agent
- Business Name
- Aclivi, LLC
- Contact Name
- Chris Brown
- Address
- 3250 Brackley Drive
- City
- Ann Arbor
- State
- MI
- ZIP
- 48105
- Country
- US
- [email protected]
- Phone
- 810 3609773
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2024-11-07 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)