FDA Registration
Active
🇫🇷 France
GastroFlex M Confocal Miniprobe
Reg #: 3004542960
·
FEI: 3004542960
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MAUNA KEA TECHNOLOGIES
- Registration Number
- 3004542960
- FEI Number
- 3004542960
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9, RUE D ENGHIEN
- City
- PARIS Ile-de-France
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K120208
Owner / Operator
- Firm Name
- Mauna Kea Technologies
- Operator Number
- 9074201
- Address
- 9, RUE D'ENGHIEN, --
- City
- PARIS
- State
- Ile-de-France
- Postal Code
- F-75010
- Country
- FR
- Correspondent
- Emmanuel - Prades
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2012-12-21 |
Proprietary Names
GastroFlex M Confocal Miniprobe
Cellvizio 100 Series
AlveoFlex M Confocal Miniprobe
Establishment Types
Manufacture Medical Device