Nano4imaging GmbH
GermanyFDA applicant, unverified FDA FEI 3013595987
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Nano4imaging GmbH makes
Nano4imaging GmbH manufactures magnetic resonance (MR)-compatible guide wires, including straight and angled designs, as well as the EmeryGlide™ guide wire for vascular procedures. These devices are intended for use in MR imaging environments to facilitate catheter navigation and intervention.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for use in the United States, where the manufacturer is based.
Catalogue
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
MRWire Guide Wire Ref K160594
Regimes: 510(k) Registry: 510(k)EmeryGlide™ (EG18008901) Ref K253262
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3013595987
- DUNS number
- 342134732
- Address
- Life Science Center, Duesseldorf North Rhine-Westphalia
Frequently asked questions
How many devices does Nano4imaging GmbH have in the registry?
The registry currently lists 4 devices for Nano4imaging GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nano4imaging GmbH's devices?
Among its 4 most recently registered devices, Nano4imaging GmbH has devices listed in FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nano4imaging GmbH's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Nano4imaging GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nano4imaging GmbH in the registry?
The most recently registered devices listed for Nano4imaging GmbH include EMERYGLIDE EG18008901, MR Wire Guide Wire Straight, MR Wire Guide Wire Angled, MRWire Guide Wire and EmeryGlide™ (EG18008901).