FDA Registration
Active
🇫🇷 France
QUANTEL MEDICAL
Reg #: 9680671
·
FEI: 3003465293
·
Expires 2026
Products
8
Proprietary Names
29
Establishment Types
5
Classifications
8
Registration Details
- Registration Name
- QUANTEL MEDICAL
- Registration Number
- 9680671
- FEI Number
- 3003465293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 rue du bois Joli, CS40015
- City
- COURNON AUVERGNE Puy-de-Dome
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K094038
- PMA Number
- P050026
Owner / Operator
- Firm Name
- QUANTEL MEDICAL
- Operator Number
- 9002489
- Address
- 1 Rue de Bois Joli, CS 40015
- City
- Cournon dAuvergne, Cedex
- State
- FR-NOTA
- Postal Code
- 63808
- Country
- FR
- Correspondent
- Bruno - Pages
US Agent
- Business Name
- OConnell Regulatory Consultants, Inc.
- Contact Name
- Maureen OConnell
- Address
- 44 Oak Street
- City
- Stoneham
- State
- MA
- ZIP
- 02180
- Country
- US
- [email protected]
- Phone
- 978 2071245
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2010-04-28 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2010-04-28 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2012-06-20 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2020-12-03 |
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2024-09-03 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | Class 2 | General, Plastic Surgery | No | 2024-06-27 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2018-04-06 |
| System, Laser, Photodynamic Therapy | MVF | Class 3 | Unknown | No | 2006-09-07 |
Proprietary Names
AXIS NANO
Suprascan Delivery System
Vitra 810
Axialis
CAPSULO
Omnicad
Multifrax Laser System
Supra 577.Y
ABSOLU
LacryDiag
COMPACT TOUCH Ophthalmic Ultrasound System
ACTIVIS
Integre LIO
VITRA MULTISPOT
SUPRA T810
VIRIDIS TWIN
OPTIMIS-II,VIRIDIS
VITRA
IRIDIS
SUPRA
Pocket III
OPTIMIS Fusion YAG/SLT
Easyret
CINESCAN FAMILY
AXIS Touch
COMPACT Touch
COMPACT TOUCH STS/UBM
AVISO
Vitra 2
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device