FDA Registration
Active
🇵🇱 Poland
Radiometer Solutions Sp. z o.o.
Reg #: 3013513377
·
FEI: 3013513377
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Radiometer Solutions Sp. z o.o.
- Registration Number
- 3013513377
- FEI Number
- 3013513377
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Stalowa 6
- City
- Stargard Zachodniopomorskie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K962158
Owner / Operator
- Firm Name
- RADIOMETER MEDICAL APS
- Operator Number
- 8020503
- Address
- AAKANDEVEJ 21, --
- City
- BROENSHOEJ
- State
- Hovedstaden
- Postal Code
- 2700
- Country
- DK
- Correspondent
- Hsiao-Qing Chow
US Agent
- Business Name
- RADIOMETER AMERICA, INC.
- Contact Name
- MATT ACKERMAN
- Address
- 250 S Kraemer Blvd
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 657 2861022
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2015-03-25 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)