Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044093

FEI Number

3005729015

Entity Name

Kolplast Ci Ltda

City/State/Country

Itupeva Sao Paulo, BR

Establishment Address

Estrada Municipal Benedito De Souza, #418 Bairro Da Mina, Itupeva Sao Paulo 13299-364, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kolplast CI Ltda (Owner Number: 9005455)

Owner / Operator Contact Address

Estrada Municipal Benedito De Souza, #418 Bairro Da Mina, Itupeva, BR-SP 13299-364, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CellPreserv Glass Slide Kolplux WL System KOLPLUX System Kolplast Vaginal Speculum Kolplast Rectosigmoidoscope Kolplast Cervical Sample Collection Kit Viral Transport Saline Solution Kolplux Vaginal Speculum CellPreserv Filter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2016-11-09
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2014-09-25
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2011-09-26
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2007-11-30
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	1992-06-03
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2017-02-14
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-08-20
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2014-09-25
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2016-11-09

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Kolplast CI Ltda

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
K963801	Young OU Brush Co.	PAP BRUSH	1997-04-09
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044093. Last updated year: 2026. Please use registration number 8044093 when referencing this establishment in official correspondence.