FDA Registration
Active
🇩🇰 Denmark
3CP Centrifuge Kit
Reg #: 3014326253
·
FEI: 3014326253
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- REAPPLIX
- Registration Number
- 3014326253
- FEI Number
- 3014326253
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bregneroedvej 133A, st. th.
- City
- Birkerod Sjalland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- BK200471
Owner / Operator
- Firm Name
- Reapplix
- Operator Number
- 10057162
- Address
- Bregneroedvej 133A
- City
- Birkerød
- State
- Sjalland
- Postal Code
- 3460
- Country
- DK
- Correspondent
- Henrik Brogaard Holmager
US Agent
- Business Name
- Biologics Consulting
- Contact Name
- MARGARET VERNON
- Address
- 100 DAINGERFIELD ROAD, SUITE 400
- City
- Alexandria
- State
- VA
- ZIP
- 22314
- Country
- US
- [email protected]
- Phone
- 720 8833633
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Peripheral Blood Processing Device For Wound Management | PMQ | Class 2 | Hematology | No | 2022-12-15 |
Proprietary Names
3CP Centrifuge Kit
3C Patch® Needle Holder
4 x (21G Needle + 3C Patch® Needle Holder)
3C Patch® Device
3CP Counterbalance
3C Patch® Kit
3CP Centrifuge
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility