FDA Device Entity Profile: SOMNOMED INC.

Known Identifiers & Locations

FEI Numbers 3005343849, 3005598536, 3009440973

Owner Operator Numbers 9071127

Locations Covered CROWS NEST New South Wales, AU; Makati City National Capital Region, PH; Plano, TX, US

Registered Establishments (3)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3005343849	SOMNOMED, LTD.	CROWS NEST New South Wales, AU	Develop Specifications But Do Not Manufacture At This Facility	View Details
3005598536	SOMNOMED INC.	Plano, TX, US	Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device	View Details
3009440973	SomnoMed Phillipines Inc.	Makati City National Capital Region, PH	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.