FDA Registration
Active
🇳🇱 Netherlands
CueSee Hypoxic
Reg #: 9681518
·
FEI: 3005695774
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EUROTROL B.V.
- Registration Number
- 9681518
- FEI Number
- 3005695774
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KEPLERLAAN 20
- City
- EDE Gelderland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K152553
Owner / Operator
- Firm Name
- EUROTROL B.V.
- Operator Number
- 9023488
- Address
- KEPLERLAAN 20, --
- City
- EDE
- State
- Gelderland
- Postal Code
- NL 6716 BS
- Country
- NL
US Agent
- Business Name
- EUROTROL INC.
- Contact Name
- Bart Maas
- Address
- 850 N Black Branch Rd
- City
- Elizabethtown
- State
- KY
- ZIP
- 42701
- Country
- US
- [email protected]
- Phone
- 502 5011180
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 2016-04-28 |
Proprietary Names
CueSee Hypoxic
Establishment Types
Manufacture Medical Device