FDA Device Entity Profile: RADIOMETER MEDICAL APS

Known Identifiers & Locations

FEI Numbers 1523456, 3002663379, 3002807968, 3007490412, 3013513377, 3014506106

Owner Operator Numbers 8020503, 9064213

Locations Covered BASEL Basel-Stadt, CH; BROENSHOEJ Hovedstaden, DK; Middleburg Heights, OH, US; New Brighton, MN, US; Stargard Zachodniopomorskie, PL

Registered Establishments (6)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1523456	RADIOMETER AMERICA, INC.	Middleburg Heights, OH, US	Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device	View Details
3002807968	RADIOMETER MEDICAL APS	BROENSHOEJ Hovedstaden, DK	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details
3007490412	Radiometer Sp. z o.o	Stargard Zachodniopomorskie, PL	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3013513377	Radiometer Solutions Sp. z o.o.	Stargard Zachodniopomorskie, PL	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3014506106	Radiometer Minneapolis	New Brighton, MN, US	Manufacture Medical Device	View Details
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH	Manufacture Medical Device for Another Party (Contract Manufacturer)	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.