FDA Registration
Active
🇩🇰 Denmark
POWERMEDIC APS
Reg #: 3003889343
·
FEI: 3003889343
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- POWERMEDIC APS
- Registration Number
- 3003889343
- FEI Number
- 3003889343
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8 Gasvaerksvej
- City
- HOLBAEK Sjalland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K134017
Owner / Operator
- Firm Name
- PowerMedic Worldwide SL
- Operator Number
- 10094726
- Address
- UR. Lorcrimar III, 01 Pta. C Esc. 6, Nueva Andalucia
- City
- Marbella
- State
- Malaga
- Postal Code
- 29660
- Country
- ES
- Correspondent
- Arne Grinsted
US Agent
- Business Name
- PowerMedic US Inc
- Contact Name
- Maja Grinsted Hillegass
- Address
- 114 FS Drive, Suite A
- City
- Viroqua
- State
- WI
- ZIP
- 54665
- Country
- US
- [email protected]
- Phone
- 608 6321033
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-12-18 |
Proprietary Names
GigaLaser
PowerLaser
Establishment Types
Manufacture Medical Device