FDA Registration
Active
🇳🇱 Netherlands
Ir-192 Source
Reg #: 9610348
·
FEI: 3002806617
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Curium Netherlands B.V.
- Registration Number
- 9610348
- FEI Number
- 3002806617
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Westerduinweg 3, 1755 LE
- City
- Petten Noord-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K953946
Owner / Operator
- Firm Name
- Curium US LLC
- Operator Number
- 10051585
- Address
- 2703 Wagner Place
- City
- Maryland Heights
- State
- MO
- Postal Code
- 63043
- Country
- US
US Agent
- Business Name
- Curium US LLC
- Contact Name
- Bridget Martin
- Address
- 2703 Wagner Pl
- City
- Maryland Heights
- State
- MO
- ZIP
- 63043
- Country
- US
- [email protected]
- Phone
- 314 3437518
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2016-04-07 |
Proprietary Names
Ir-192 Source
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)