FDA Device Entity Profile: GENTELL

Known Identifiers & Locations

FEI Numbers 1000522686, 3002265219, 3002806830, 3003636207, 3009348823

Owner Operator Numbers 10026501, 10039061

Locations Covered Bristol, PA, US; DEVELOPMENT Jiangsu, CN; Marlborough Wiltshire, GB; Masterton Wellington, NZ; TORONTO Ontario, CA

Registered Establishments (5)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2530957	GENTELL	Bristol, PA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
3003636207	DERMA SCIENCES NANTONG INCORPORATION	DEVELOPMENT Jiangsu, CN	Manufacture Medical Device	View Details
3009348823	ManukaMed Limited Partnership	Masterton Wellington, NZ	Manufacture Medical Device	View Details
9680091	DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)	TORONTO Ontario, CA	Manufacture Medical Device	View Details
9680731	FIRST WATER RAMSBURY LTD	Marlborough Wiltshire, GB	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical 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

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.