FDA Registration
Active
🇨🇿 Czechia
ELLA-CS, S.R.O.
Reg #: 3004070722
·
FEI: 3004070722
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ELLA-CS, S.R.O.
- Registration Number
- 3004070722
- FEI Number
- 3004070722
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Milady Horakove 504/45 Trebes
- City
- Hradec Kralove
- Country
- CZ
Regulatory Submissions
- 510(k) Number
- K112017
Owner / Operator
- Firm Name
- ELLA-CS, s.r.o.
- Operator Number
- 10046400
- Address
- Milady Horakove 504/45, Trebes
- City
- Hradec Kralove
- State
- CZ-521
- Postal Code
- 500 06
- Country
- CZ
- Correspondent
- Jan Honegr
US Agent
- Business Name
- RAUMEDIC Inc.
- Contact Name
- Jeremy Smith
- Address
- 235 Broadpointe Dr
- City
- Mills River
- State
- NC
- ZIP
- 28759
- Country
- US
- [email protected]
- Phone
- 828 4903262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2014-03-18 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)