Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004050854

FEI Number

3004050854

Entity Name

Tricol Biomedical, INC.

City/State/Country

PORTLAND, OR, US

Establishment Address

720 SW Washington St Ste 200, PORTLAND, OR 97205, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Tricol Biomedical, INC. (Owner Number: 9053189)

Owner / Operator Contact Address

720 SW Washington Street, SUITE 200, Portland, OR 97205, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102546

PMA Number

N/A

All Registered Proprietary Names

ChitoPulse HemCon ChitoDot OneStop Bandage OneStop Vascular Pre-slit OneStop Vascular GuardaCare XR Surgical HemCon Patch PRO HemCon Bandage PRO ChitoGauze XR PRO (SafeGuard) ChitoGauze XR PRO ChitoGauze XR2 PRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2017-09-12
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2018-12-31
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2015-12-21
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2015-12-21
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2013-02-06
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2013-02-06
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2013-02-06

Official Correspondent

Maire Ni Beilliu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tricol Biomedical, INC.

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
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

Similar Registrations

Registration Number	Establishment Name	Location
1531062	E-BEAM SERVICES, INC.	LEBANON, OH, US
9680515	TONTARRA MEDIZINTECHNIK GMBH	WURMLINGEN Baden-Wurttemberg, DE
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
2950160	WRIGHT ENGINEERED PLASTICS, INC.	Santa Rosa, CA, US
3005809810	Jarit GmbH	Rietheim-Weilheim Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004050854. Last updated year: 2026. Please use registration number 3004050854 when referencing this establishment in official correspondence.