FDA Registration
Active
🇬🇷 Greece
Medicon Hellas Total Bilirubin
Reg #: 3006716639
·
FEI: 3006716639
·
Expires 2025
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MEDICON HELLAS SA
- Registration Number
- 3006716639
- FEI Number
- 3006716639
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- MELITONA 5-7
- City
- GERAKAS Attiki
- Country
- GR
Regulatory Submissions
- 510(k) Number
- K200898
Owner / Operator
- Firm Name
- MEDICON HELLAS SA
- Operator Number
- 10036719
- Address
- MELITONA 5-7
- City
- GERAKAS
- State
- Attiki
- Postal Code
- 15344
- Country
- GR
- Correspondent
- SOTIRIA MITROPOULOU
US Agent
- Business Name
- Diatron US Inc.
- Contact Name
- Frank Matuszak
- Address
- 12601 NW 115th Avenue Suite A 113
- City
- Medley
- State
- FL
- ZIP
- 33178
- Country
- US
- [email protected]
- Phone
- 833 2287931
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2023-10-05 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2023-10-05 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2023-10-05 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2023-10-05 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2023-10-05 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2023-10-05 |
Proprietary Names
Medicon Hellas Total Bilirubin
Medicon Hellas Albumin
Medicon Hellas Direct Bilirubin
Medicon Hellas Creatinine
Medicon Hellas Urea Nitrogen
Medicon Hellas Calcium
Medicon Hellas Glucose
Establishment Types
Manufacture Medical Device