Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005004019

FEI Number

3005004019

Entity Name

COVALON TECHNOLOGIES INC.

City/State/Country

MISSISSAUGA Ontario, CA

Establishment Address

1660 TECH AVENUE, UNIT 5, MISSISSAUGA Ontario L4W 5S7, CA

Establishment Type(s)

Foreign Private Label Distributor,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

COVALON TECHNOLOGIES, LTD. (Owner Number: 9070081)

Owner / Operator Contact Address

1660 TECH AVENUE, UNIT 5, MISSISSAUGA, CA-ON L4W 5S7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CovaClear IV CovaView IV DermaCol BioStep ColActive Plus BioStep Ag Collagen Dressing DermaCol Ag ColActive Plus Ag Collagen Dressing with Silver CovaWound Alginate SurgiClear Antimicrobial Clear Silicone Adhesive Dressing With Cholorhexidine and Silver CovaWound Foam;CovaWound Hydrocolloid;CovaWound Silicone;CovaWound Superabsorbent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2020-01-02
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2005-02-04
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2015-03-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-11-23
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2015-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

Christina Mitchell Business: COVALON TECHNOLOGIES INC Email: cmitchell@covalon.com Phone: (206) 5137591

Related Public Records

Same Entity

COVALON TECHNOLOGIES, LTD.

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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3005023997	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	SHANGHAI, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005004019. Last updated year: 2026. Please use registration number 3005004019 when referencing this establishment in official correspondence.