Igea, S.r.l.
Country not established
- Devices
- 1
What Igea, S.r.l. makes
Igea, S.R.L. manufactures the ELPER™ Barrier Integrity Monitoring system, a device designed to assess and verify the sterility of barrier systems in medical packaging, ensuring contamination prevention during storage and transport.
The ELPER™ Barrier Integrity Monitor is classified as a Class II medical device under FDA regulations and is listed via a 510(k) clearance. The company is based in the United States.
Catalogue
Elper(Tm) Barrier Integrity Monitoring Ref K931153
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Igea, S.R.L. have in the registry?
The registry currently lists 1 device for Igea, S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Igea, S.R.L.'s devices?
Among its 1 most recently registered device, Igea, S.R.L. has devices listed in FDA 510(k) (1 device).
What are the newest devices from Igea, S.R.L. in the registry?
The most recently registered devices listed for Igea, S.R.L. include ELPER(TM) BARRIER INTEGRITY MONITORING.