Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005405896

FEI Number

3005405896

Entity Name

BLUE.S4

City/State/Country

Belleville Ontario, CA

Establishment Address

269 University Ave, Belleville Ontario K8N 5S3, CA

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Blue.S4 (Owner Number: 9078622)

Owner / Operator Contact Address

269 University Ave, --, Belleville, CA-ON K8N 5S3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RT-600-LN-BLK RT-600-LN-GRY RT-600-LP-BLK RT-600-SP-BLK RT-600-SN-BLK RT-600-SN-GRY Instrument table - Atlas Pedestal 230V H-Base Table 2-UP with controller and line-voltage outlets Instrument table - Atlas Pedestal H-Base Table 2_UP lx with controller and line-voltage outlets Phantom Table - 240V Phantom Table - 120V Table 3-UP with controller and line-voltage outlets Instrument table - Atlas wheelchair Pedestal 230V U-Base Instrument table - Atlas wheelchair Pedestal U-Base S4OPTIK Examination Chair - Model 1800-CH-H S4OPTIK Combination Chair & Stand - Model 2000-CB-H S4OPTIK Combination Chair & Stand - Model 2500-CB-H S4OPTIK Examination Chair - Model 2500-CH-H S4OPTIK Combination Chair & Stand - Model 1800-CB-H Lombart CS6 Chair - Model CS-6-CH-H S4OPTIK Examination Chair & Stand - Model 1000-CB-H Marco Bravo 2 Chair - Model BR2-CH-H S4OPTIK Combination Chair & Stand - Model 2000-CB-H-L S4OPTIK Chair Model 1000-CH-H S4OPTIK Examination Chair - Model 2000-CH-H S4OPTIK Combination Chair & Stand - Model 2500-CB-H-L PD-1-S4 PD-1 S4OPTIK Exam Stool with backrest S4OPTIK Exam Stool without backrest S4OPTIK INSTRUMENT STAND - MODEL 1600-ST S4OPTIK INSTRUMENT STAND - MODEL 2000-ST Lombart CS6 STAND - Model CS-6-ST Marco Bravo 2 Stand-Model BR2-ST S4OPTIK POWERED STOOL - MODEL 9000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2026-03-25
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2005-10-17
HME	Chair, Ophthalmic, Ac-Powered	Ophthalmic	Class 1	886.1140	2005-10-17
HLH	Pupillometer, Manual	Ophthalmic	Class 1	886.1700	2026-03-25
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2026-06-08
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2005-10-17

Official Correspondent

Mary Anne Bembridge

US Agent Details

Rich Wynkoop Business: Sunbreak Investments, LLC dba Vision28 Email: rich@vision28.com Phone: (541) 6049654

Related Public Records

Same Entity

Blue.S4

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 3005405896. Last updated year: 2026. Please use registration number 3005405896 when referencing this establishment in official correspondence.