FDA Registration
Active
🇩🇪 Germany
SFM Medical Devices GmbH
Reg #: 1000632857
·
FEI: 1000632857
·
Expires 2026
Products
11
Proprietary Names
15
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- SFM Medical Devices GmbH
- Registration Number
- 1000632857
- FEI Number
- 1000632857
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Brueckenstrasse 5
- City
- Waechtersbach Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K183187
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 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2017-05-22 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2026-06-17 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2007-07-23 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2017-06-22 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2017-05-22 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2024-12-30 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2024-12-30 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2006-06-16 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2009-08-11 |
| System/Device, Pharmacy Compounding | NEP | Class 2 | General Hospital | No | 2007-03-29 |
Proprietary Names
AccessKit, 10G, Single Pack, Bevel, Side Opening, sterile
AccessKit, 10G, Single Pack, Diamond, Side Opening, sterile
AccessKit, 10G, Single Pack, Diamond, End Opening, sterile
AccessKit, 10G, Single Pack, Bevel, End Opening, sterile
Implanter cannula
Cannula for subcutaneous implant/pellet administration
nexoderm® Dermal Curette
Biopsy Kit, 10G, sterile
nextaro® va, 15mm, 5µm (REF number: 20037)
nextaro® va 13, 5µm Filter (REF number 20042)
Access Drill, 10G, sterile
PROBE, RADIOFREQUENCY LESION
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
Manufacture Medical Device for Another Party (Contract Manufacturer)