FDA Device Entity Profile: Auditdata A/S

Known Identifiers & Locations

FEI Numbers 3004052117, 3008386587, 3013596041, 3030089857

Owner Operator Numbers 10032598

Locations Covered Copenhagen Hovedstaden, DK; Malmo Skane, SE; Pottstown, PA, US; Wroclaw Dolnoslaskie, PL

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3004052117	Auditdata, LLC	Pottstown, PA, US	Complaint File Establishment per 21 CFR 820.198	View Details
3008386587	Auditdata A/S	Copenhagen Hovedstaden, DK	Export Device to the United States But Perform No Other Operation on Device,Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Foreign Private Label Distributor	View Details
3013596041	Inission Syd AB (Malmo AB)	Malmo Skane, SE	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3030089857	Nordes Sp. z o.o.	Wroclaw Dolnoslaskie, PL	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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