FDA Registration
Active
🇫🇮 Finland
ARCTIC BIOMATERIALS OY
Reg #: 3015780293
·
FEI: 3015780293
·
Expires 2026
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- ARCTIC BIOMATERIALS OY
- Registration Number
- 3015780293
- FEI Number
- 3015780293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Arvo Ylpon katu 41
- City
- Tampere Pirkanmaa
- Country
- FI
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
- Sanna Ritala
US Agent
- Business Name
- Paladin Medical Inc
- Contact Name
- Elaine Duncan
- 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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-01-24 |
| Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate | OJB | Class 2 | Orthopedic | No | 2022-09-09 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2022-02-07 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2022-05-17 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-06-30 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2022-02-07 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2022-09-09 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2020-01-24 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2020-01-24 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)