FDA Device Entity Profile: GN Hearing A/S

Known Identifiers & Locations

FEI Numbers 2182204, 3003303986, 3005650109, 3011927597, 3026048380

Owner Operator Numbers 2182204

Locations Covered BALLERUP Hovedstaden, DK; Kulai Johor, MY; Senai Johor, MY; Shakopee, MN, US; XIAMEN Fujian, CN

Registered Establishments (5)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2182204	GN Hearing Care Corporation	Shakopee, MN, US	Repack or Relabel Medical Device	View Details
3003303986	GN RESOUND CHINA, LTD.	XIAMEN Fujian, CN	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3005650109	GN Hearing A/S	BALLERUP Hovedstaden, DK	Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device	View Details
3011927597	GN ReSound (Malaysia) Sdn Bhd.	Kulai Johor, MY	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3026048380	GN ReSound (Malaysia) Sdn. Bhd	Senai Johor, MY	Export Device to the United States But Perform No Other Operation on Device,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

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