FDA Registration
Active
🇩🇰 Denmark
RADIOMETER MEDICAL APS
Reg #: 3002807968
·
FEI: 3002807968
·
Expires 2025
Products
12
Proprietary Names
0
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- RADIOMETER MEDICAL APS
- Registration Number
- 3002807968
- FEI Number
- 3002807968
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- AAKANDEVEJ 21
- City
- BROENSHOEJ Hovedstaden
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K092686
Owner / Operator
- Firm Name
- Radiometer Medical ApS
- Operator Number
- 9064213
- 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 |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2010-12-02 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2010-12-02 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2010-12-02 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2010-12-02 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2010-12-02 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2010-12-02 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2010-12-02 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2010-12-02 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2010-12-02 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2010-12-02 |
| Assay, Fetal Hemoglobin | KQI | Class 2 | Hematology | No | 2010-12-02 |
| Assay, Carboxyhemoglobin | GHS | Class 2 | Hematology | No | 2010-12-02 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device