Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006784948

FEI Number

3006784948

Entity Name

BIOMED LABORATORIES LLC

City/State/Country

Dallas, TX, US

Establishment Address

8181 Eastpoint Drive, Dallas, TX 75227, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIOMED LABORATORIES LLC (Owner Number: 9103441)

Owner / Operator Contact Address

8181 Eastpoint Drive, Dallas, TX 75227, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BIAKOS Antimicrobial Skin & Wound Cleanser Rochal BIAKOS Antimicrobial Wound Gel Vashe Wound Solution OTC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-10-01
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-08-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-08-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-12-20
SEJ	Wound Dressings Containing Topical Analgesics	Unknown	Class U	N/A	2016-11-09
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2010-11-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-09-15
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-06-01
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2018-07-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2014-11-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2014-10-06

Official Correspondent

Jason Troutman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOMED LABORATORIES LLC

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
K092086	Amerx Health Care Corp.	AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027	2009-07-30
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01

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-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**

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3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006784948. Last updated year: 2026. Please use registration number 3006784948 when referencing this establishment in official correspondence.