FDA Registration
Active
🇩🇰 Denmark
R82 A/S
Reg #: 3001657382
·
FEI: 3001657382
·
Expires 2026
Products
9
Proprietary Names
36
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- R82 A/S
- Registration Number
- 3001657382
- FEI Number
- 3001657382
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PARALLELVEJ 3
- City
- GEDVED Midtjylland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K151492
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 QA/RA
- Contact Name
- Gio Espinosa
- Address
- 5201 Woodward Dr
- City
- Stevens Point
- State
- WI
- ZIP
- 54481
- Country
- US
- [email protected]
- Phone
- 715 5707860
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stroller, Adaptive | LBE | Class 1 | Physical Medicine | No | 2018-08-06 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2018-08-06 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2002-03-09 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2014-08-12 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2014-08-12 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2002-03-09 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2009-01-09 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2002-03-09 |
| Table, Powered | INQ | Class 1 | Physical Medicine | No | 2009-01-11 |
Proprietary Names
Kudu
Crocodile
Pony
Mustang
Flamingo
Swan
Heron
Wombat Living
Chilla
Stingray frame
Swan Curo
Flamingo High-Low
Flamingo Curo
Penguin
Orca
Caribou
Gazelle PS
Toucan
Meerkat
Rabbit Up
Addax
Multi Frame
Stingray Frame
Cricket
Strong Base
Manatee
Stingray Seat
High-Low:Xo
X:panda
Scallop
X:Panda Shape
High-Low:xo
Stingray seat
x:panda
x:panda shape
Multi frame
Establishment Types
Manufacture Medical Device