FDA Registration
Active
🇩🇪 Germany
BIOANALYTIC GMBH
Reg #: 3003393069
·
FEI: 3003393069
·
Expires 2026
Products
4
Proprietary Names
22
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BIOANALYTIC GMBH
- Registration Number
- 3003393069
- FEI Number
- 3003393069
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Waldmatten 10-13
- City
- Umkirch/Freiburg Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- Bioanalytic GmbH
- Operator Number
- 10030817
- Address
- Waldmatten 10-13
- City
- Umkirch/Freiburg
- State
- Baden-Wurttemberg
- Postal Code
- 79224
- Country
- DE
US Agent
- Business Name
- FDAbasics LLC
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fluid, Diluting, Manual Cell | JCG | Class 1 | Hematology | No | 2009-11-18 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 2010-01-13 |
| Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality | JMZ | Class 1 | Clinical Chemistry | No | 2018-01-31 |
| Hemocytometer | GHO | Class 1 | Hematology | No | 2011-08-12 |
Proprietary Names
Thrombopur
Thrombo-TIC
Eos-TIC
Leuko-TIC SF
Reti-TIC
LeukoCount
Leukopur
EosCount
Leuko-TIC
Sperm-TIC
ThromboCount
Leuko-TIC VT
Erypur
EryCount
Ery-TIC
TIC Capillary Pack 10µl
TIC Capillary Pack 20µl
TIC Capillary Pack 5µl
Bryopette
Osmolality Calibration Standard
Hemacytometer
Hemacytometer disposable
Establishment Types
Manufacture Medical Device