FDA Registration
Active
🇫🇮 Finland
iCare HOME2
Reg #: 3010287677
·
FEI: 3010287677
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MARIACHI OY
- Registration Number
- 3010287677
- FEI Number
- 3010287677
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kaarinantie 700
- City
- Littoinen Varsinais-Suomi
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K211355
Owner / Operator
- Firm Name
- Mariachi Oy
- Operator Number
- 10043088
- Address
- Kaarinantie 700
- City
- Littoinen
- State
- Varsinais-Suomi
- Postal Code
- 20660
- Country
- FI
- Correspondent
- Pasi Hatakka
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2022-02-04 |
Proprietary Names
iCare HOME2
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)