Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014271678

FEI Number

3014271678

Entity Name

BioLink Systems, LLC

City/State/Country

Covington, KY, US

Establishment Address

715 Bakewell Street, Covington, KY 41011, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BioLink Systems, LLC (Owner Number: 10057030)

Owner / Operator Contact Address

715 Bakewell Street, Unit C, Covington, KY 41011, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioLink Incontinence Monitoring System BioLink Patient Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2021-01-28

Official Correspondent

Ken Heyl

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioLink Systems, LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014271678. Last updated year: 2026. Please use registration number 3014271678 when referencing this establishment in official correspondence.