Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000165286

FEI Number

1000165286

Entity Name

Biomerics Winston-Salem

City/State/Country

Winston Salem, NC, US

Establishment Address

2701 Boulder Park Ct, Winston Salem, NC 27101, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biomerics Winston-Salem (Owner Number: 9050621)

Owner / Operator Contact Address

2701 BOULDER PARK COURT, --, Winston Salem, NC 27101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CeQur Simplicity Patch Replacement Kit CeQur Simplicity Starter Kit CeQur Simplicity Inserter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OPP	Pump, Infusion, Insulin Bolus	General Hospital	Class 2	880.5725	2021-12-20

Official Correspondent

Greicy Barahona

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biomerics Winston-Salem

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3007871880	CeQur Corporation	Greenville, SC, US
3015218509	CeQur SA	Horw Luzern, CH
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000165286. Last updated year: 2026. Please use registration number 1000165286 when referencing this establishment in official correspondence.