Biomerics Mebane

FDA Device Registration & Listing · Mebane, NC, US · Registration 1057196

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1057196
FEI Number
1000140478
Entity Name
Biomerics Mebane
City/State/Country
Mebane, NC, US
Establishment Address
1405 Dogwood Way, Mebane, NC 27302, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Biomerics Mebane (Owner Number: 10030082)
Owner / Operator Contact Address
1405 Dogwood Way, Mebane, NC 27302, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Irrisept Antimicrobial Wound Lavage

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FQH Lavage, Jet General Hospital Class 2 880.5475 2023-05-30

Official Correspondent

Jake Wakley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biomerics Mebane
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K213616 Becton, Dickinson and Company BD Surgiphor Antimicrobial Irrigation System 2022-03-23

Similar Registrations

Registration Number Establishment Name Location
3032611331 CALEB CO., LTD. Won-Ju-Si Gangwon, KR
3012964172 ELITE MEDTEK(JIANGSU) CO., LTD Changzhou City Jiangsu, CN
3009217531 Eurofins STERIPAC GMBH Calw-Altburg Baden-Wurttemberg, DE
1718850 LivaNova USA, INC. ARVADA, CO, US
3045076544 BEIJING YUEWEI MEDICAL TECHNOLOGY CO., LTD Beijing, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1057196. Last updated year: 2026. Please use registration number 1057196 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.