FDA Registration
Active
🇩🇰 Denmark
SwimCount® Harvester
Reg #: 3015550658
·
FEI: 3015550658
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MOTILITYCOUNT APS
- Registration Number
- 3015550658
- FEI Number
- 3015550658
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gl. Koege Landevej 57 2
- City
- Valby Hovedstaden
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K241348
Owner / Operator
- Firm Name
- MotilityCount ApS
- Operator Number
- 10061002
- Address
- Gl. Koege Landevej 57
- City
- Valby
- State
- Hovedstaden
- Postal Code
- DK-2500
- Country
- DK
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2025-03-19 |
Proprietary Names
SwimCount® Harvester
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device