FDA Registration
Active
🇨🇿 Czechia
safemed medical devices s.r.o.
Reg #: 3007221462
·
FEI: 3007221462
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- safemed medical devices s.r.o.
- Registration Number
- 3007221462
- FEI Number
- 3007221462
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Trabantska 292
- City
- Prague Praha, Hlavni Mesto
- Country
- CZ
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 | 2019-04-29 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2024-12-30 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2024-12-30 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2009-08-11 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2009-08-11 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2026-06-17 |
Proprietary Names
nextaro® va, 15mm, 5µm (REF number: 20037)
nextaro® va 13, 5µm Filter (REF number 20042)
PROBE, RADIOFREQUENCY LESION
nexoderm® Dermal Curette
nextaro® v, 20/20 (REF number 20027)
nextaro® v, 20/20, 5µm (REF number 20040)
nextaro® v 20/32 (REF number 20035)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)