Irema USA, Ltd.
Country not established
- Devices
- 2
What Irema USA, Ltd. makes
The company manufactures disposable surgical face masks designed for single-use in clinical and procedural settings to reduce infection risk.
These products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
Disposable Surgical Face Mask Ref K875172
Regimes: 510(k) Registry: 510(k)Disposable Surgical Face Masks Ref K812675
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Irema USA, Ltd. have in the registry?
The registry currently lists 2 devices for Irema USA, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Irema USA, Ltd.'s devices?
Among its 2 most recently registered devices, Irema USA, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Irema USA, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Irema USA, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Irema USA, Ltd. in the registry?
The most recently registered devices listed for Irema USA, Ltd. include DISPOSABLE SURGICAL FACE MASK and DISPOSABLE SURGICAL FACE MASKS.