sfm medical devices GmbH
DE-MF-000008166 · Germany · Waechtersbach
sfm medical devices GmbH is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 15 |
|---|
Most frequent device types declared: Transfer Needle, nextaro®, nextaro® v, nextaro® va.
Among these devices, 15 are declared sterile.
Devices declared under this manufacturer
- Doppelendkanüle (Einfachschliff, 1,5 mm x 46,5 mm; Nadellänge 10 mm
- Doppelendkanüle (Einfachschliff, 1,5 mm x 46,5 mm; Nadellänge 21 mm
- Doppelendkanüle (Einfachschliff, 1,5 mm x 46,5 mm; Nadellänge 22 mm
- Doppelendkanüle (Einfachschliff, 1,5 mm x 46,5 mm; beide Seiten gle
- Doppelendkanüle (Pencil-Point-Schliff, 1,0 mm x 49 mm; Nadellänge P
- Transfer Needle (single bevel, 1,5 mm x 46,5 mm; same needle length on
- nextaro® 20/20, 15 µm nominal
- nextaro® 32/32, 15 μm nominal
- nextaro® v, 20/20, 15 μm nominal
- nextaro® v, 20/20, 5 μm
- nextaro® v, 20/32, 15 μm nominal
- nextaro® va 20 mm, 15µm nominal
Showing 12 of 15 declared devices.
Catalogue references include 20004, 20027, 20031, 20036, 20042, 71281.
European nomenclature codes declared: A0704, A0499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SFM Medical Devices GmbH (DE) · FDA 1000632857 |
| Devices in EUDAMED | 15 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 46.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SFM MEDICAL DEVICES GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2023-05-30 |
Licence types: Device Family (2).
Licensed under: NEXTARO TRANSFER DEVICE, NEXTARO VA VIAL ADAPTER.
North American profile: Both markets. sfm medical devices GmbH is registered in both the United States and Canada.