FDA Registration
Inactive
🇫🇮 Finland
BIOMENDEX OY
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOMENDEX OY
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Korkeakoulunkatu 1
- City
- Tampere Pirkanmaa
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K253524
Owner / Operator
- Firm Name
- Biomendex Oy
- Operator Number
- 10095952
- Address
- Korkeakoulunkatu 1
- City
- Tampere
- State
- Pirkanmaa
- Postal Code
- 33720
- Country
- FI
- Correspondent
- Pasi E Kankaanpaeae
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 Nw 12th St Ste 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 305 5599373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2026-05-28 |
Proprietary Names
Adaptos(R)Fuse Bone Graft
Establishment Types
Manufacture Medical Device