FDA Registration
Active
🇫🇷 France
DYN'R
Reg #: 3008317830
·
FEI: 3008317830
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- DYN'R
- Registration Number
- 3008317830
- FEI Number
- 3008317830
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1480 Avenue Armenie Pole Yvon Morandat
- City
- GARDANNE. Bouches-du-Rhone
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K942779
Owner / Operator
- Firm Name
- Dyn'R
- Operator Number
- 10031870
- Address
- 1480 Avenue Armenie, Pole Yvon Morandat
- City
- Gardanne
- State
- Bouches-du-Rhone
- Postal Code
- 13120
- Country
- FR
- Correspondent
- Gordon Fairbairn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2011-02-27 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2010-03-17 |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2016-09-23 |
| Calibrator, Volume, Gas | BXW | Class 1 | Anesthesiology | No | 2010-12-06 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2010-12-06 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2010-12-06 |
Proprietary Names
SDX System
SDX System with Gating Module
SDX System special edition with Gating Module
SDX Calibration Syringe
Nose Clip for SDX System
Mouthpiece for SDX System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device