FDA Registration
Active
🇨🇿 Czechia
KELABIT S.R.O.
Reg #: 3010640396
·
FEI: 3010640396
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KELABIT S.R.O.
- Registration Number
- 3010640396
- FEI Number
- 3010640396
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Na Mlynici 13
- City
- Ostrava Moravskoslezsky Kraj
- Country
- CZ
Regulatory Submissions
- 510(k) Number
- K133176
Owner / Operator
- Firm Name
- Kelabit s.r.o.
- Operator Number
- 10051198
- Address
- Na Mlynici 13
- City
- Privoz
- State
- Ostrava-Mesto
- Postal Code
- 702 00
- Country
- CZ
- Correspondent
- Tomas Sotak
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2016-12-20 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device