FDA Device Entity Profile: 3Shape A/S

Known Identifiers & Locations

FEI Numbers 3005940400, 3010728558, 3015172511, 3015193486

Owner Operator Numbers 10023901

Locations Covered Copenhagen Hovedstaden, DK; Morrisville, NC, US; New Providence, NJ, US; Szczecin Zachodniopomorskie, PL

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3005940400	3Shape A/S	Copenhagen Hovedstaden, DK	Develop Specifications But Do Not Manufacture At This Facility	View Details
3010728558	3shape inc	New Providence, NJ, US	Complaint File Establishment per 21 CFR 820.198	View Details
3015172511	3Shape Poland Sp. zo.o	Szczecin Zachodniopomorskie, PL	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3015193486	3Shape Inc.	Morrisville, NC, US	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.