FDA Registration
Active
🇫🇮 Finland
Catalyst
Reg #: 3007615597
·
FEI: 3007615597
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INNOKAS MEDICAL OY
- Registration Number
- 3007615597
- FEI Number
- 3007615597
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Vihikari 10
- City
- KEMPELE Pohjois-Pohjanmaa
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K113276
Owner / Operator
- Firm Name
- Innokas Yhtyma Oy
- Operator Number
- 10026175
- Address
- Vihikari 10
- City
- KEMPELE
- State
- Pohjois-Pohjanmaa
- Postal Code
- 90440
- Country
- FI
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2016-11-09 |
Proprietary Names
Catalyst
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)