FDA Registration
Active
🇩🇰 Denmark
Multi frame
Reg #: 3001657382
·
FEI: 3001657382
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- R82 A/S
- Registration Number
- 3001657382
- FEI Number
- 3001657382
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PARALLELVEJ 3
- City
- GEDVED Midtjylland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K100084
Owner / Operator
- Firm Name
- R82 A/S
- Operator Number
- 9034750
- Address
- Parallelvej 3, --
- City
- Gedved
- State
- Midtjylland
- Postal Code
- DK-8751
- Country
- DK
- Correspondent
- Stefan Ryom
US Agent
- Business Name
- Director RA/QA
- Contact Name
- Michael Baron
- Address
- 13137 Bleinheim Ln
- City
- Matthews
- State
- NC
- ZIP
- 28105
- Country
- US
- [email protected]
- Phone
- 310 9975528
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2018-08-06 |
Proprietary Names
Multi frame
Establishment Types
Manufacture Medical Device