FDA Registration
Active
🇨🇿 Czechia
GCE, s.r.o.
Reg #: 3003207908
·
FEI: 3003207908
·
Expires 2026
Products
3
Proprietary Names
18
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- GCE, s.r.o.
- Registration Number
- 3003207908
- FEI Number
- 3003207908
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GCE, s.r.o., Zizkova 381
- City
- Chotebor Havlickuv Brod
- Country
- CZ
Owner / Operator
- Firm Name
- GCE s.r.o.
- Operator Number
- 10080413
- Address
- GCE s.r.o., Zizkova 381
- City
- Chotebor
- State
- Havlickuv Brod
- Postal Code
- 58301
- Country
- CZ
- Correspondent
- Lukas Palek
US Agent
- Business Name
- Ohio Medical, LLC
- Contact Name
- Jessica Barrile
- Address
- 1111 Lakeside Drive
- City
- Gurnee
- State
- IL
- ZIP
- 60031
- Country
- US
- [email protected]
- Phone
- 847 8556318
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2021-05-28 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2021-02-02 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2021-02-01 |
Proprietary Names
GCE Zen-O Lite Portable Oxygen Concentrator Model RS-00600
GCE Zen-O Lite Clarity Portable Oxygen Concentrator Model RS-00600C
ARYA ZenO Lite Portable Oxygen Concentrator RS-00600
GCE Zen-O Portable Oxygen Concentrator Model RS-00500
GCE Zen-O Clarity Portable Oxygen Concentrator Model RS-00500C
Amvex Flowmeter
MediFlowTec
MediMeter
MediVital E
Mediselect II
Varimed+
MediReg II
MediTec
Varimed
MediFlow Ultra
MediVitop
Ministar 2
MediVital
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device