FDA Registration
Active
🇨🇿 Czechia
nextaro® v 20/32 (REF number 20035)
Reg #: 3007221462
·
FEI: 3007221462
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- safemed medical devices s.r.o.
- Registration Number
- 3007221462
- FEI Number
- 3007221462
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Trabantska 292
- City
- Prague Praha, Hlavni Mesto
- Country
- CZ
Regulatory Submissions
- 510(k) Number
- K240748
Owner / Operator
- Firm Name
- sfm medical devices GmbH
- Operator Number
- 9088579
- Address
- Brueckenstrasse 5, --
- City
- Waechtersbach
- State
- DE-NOTA
- Postal Code
- 63607
- Country
- DE
US Agent
- Business Name
- Phil Triolo and Associates LC
- Contact Name
- Ryan O'Callaghan
- Address
- 1357 S 900 E
- City
- Salt Lake City
- State
- UT
- ZIP
- 84105
- Country
- US
- [email protected]
- Phone
- 801 5732651
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2024-04-22 |
Proprietary Names
nextaro® v 20/32 (REF number 20035)
nextaro® v, 20/20 (REF number 20027)
nextaro® v, 20/20, 5µm (REF number 20040)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)