Biomerics Nle
United Statesfrom the FDA registration address FDA FEI 3016079756
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Biomerics Nle makes
Biomerics Nle manufactures guidewires for vascular procedures, including the BNLE Access Guidewire and the BNLE Hydrophilic Jacketed Peripheral Guidewire, designed for use in peripheral and coronary interventions.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
BNLE Access Guidewire Ref K221390
Regimes: 510(k) Registry: 510(k)BNLE Hydrophilic Jacketed Peripheral Guidewire Ref K232662
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3016079756
- Address
- 246 Main St, Monroe, CT, 06468
Frequently asked questions
How many devices does Biomerics Nle have in the registry?
The registry currently lists 2 devices for Biomerics Nle. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomerics Nle's devices?
Among its 2 most recently registered devices, Biomerics Nle has devices listed in FDA 510(k) (2 devices).
What risk classes do Biomerics Nle's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biomerics Nle's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biomerics Nle in the registry?
The most recently registered devices listed for Biomerics Nle include BNLE Access Guidewire and BNLE Hydrophilic Jacketed Peripheral Guidewire.