FDA Registration
Active
🇩🇰 Denmark
POWER LASER
Reg #: 3003889343
·
FEI: 3003889343
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- POWERMEDIC APS
- Registration Number
- 3003889343
- FEI Number
- 3003889343
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 Gasvaerksvej
- City
- HOLBAEK Sjalland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K070516
Owner / Operator
- Firm Name
- POWERMEDIC APS
- Operator Number
- 9052408
- Address
- GASVAERKSVEJ 8, --
- City
- HOLBAEK
- State
- DK-NOTA
- Postal Code
- DK-4300
- Country
- DK
- 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 4062020
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2007-12-06 |
Proprietary Names
POWER LASER
POWERmedicLASER
iPowerLaser
Establishment Types
Manufacture Medical Device