FDA Registration
Active
🇫🇮 Finland
ARCTIC BIOMATERIALS OY
Reg #: 3015780293
·
FEI: 3015780293
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ARCTIC BIOMATERIALS OY
- Registration Number
- 3015780293
- FEI Number
- 3015780293
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Arvo Ylpon katu 41
- City
- Tampere Pirkanmaa
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K070784
Owner / Operator
- Firm Name
- Arctic Biomaterials Oy
- Operator Number
- 10062418
- Address
- Arvo Ylpon katu 41
- City
- Tampere
- State
- Pirkanmaa
- Postal Code
- 33520
- Country
- FI
- Correspondent
- Hillevi Peltola
US Agent
- Business Name
- Paladin Medical, Inc.
- Contact Name
- LaVonne Waldon
- Address
- 415 Valley View Trail
- City
- Houlton
- State
- WI
- ZIP
- 54082
- Country
- US
- [email protected]
- Phone
- 715 5496035
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2022-02-07 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)