FDA Registration
Active
🇨🇭 Switzerland
Cordiana Dx16
Reg #: 3022780114
·
FEI: 3022780114
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CORDIANA MEDICAL INFORMATICS AG
- Registration Number
- 3022780114
- FEI Number
- 3022780114
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Platz 4
- City
- Root D4 Luzern
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K201060
Owner / Operator
- Firm Name
- Cordiana Medical Informatics AG
- Operator Number
- 10085146
- Address
- Platz 4
- City
- Root D4
- State
- Luzern
- Postal Code
- 6039
- Country
- CH
- Correspondent
- Johan Sandberg
US Agent
- Business Name
- Zoe Medical Inc.
- Contact Name
- Bengt Hermanrud
- Address
- 460 Boston St
- City
- Topsfield
- State
- MA
- ZIP
- 01983
- Country
- US
- [email protected]
- Phone
- 978 8771410
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-05-11 |
Proprietary Names
Cordiana Dx16
Establishment Types
Manufacture Medical Device