Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023548698

FEI Number

3023548698

Entity Name

Lindo Manufacturing

City/State/Country

Swansea, MA, US

Establishment Address

1658 GAR Highway, Unit 3, Swansea, MA 02777, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Lindo Manufacturing, LLC (Owner Number: 10088656)

Owner / Operator Contact Address

1658 GAR Highway, Unit 3, Swansea, MA 02777, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ScarMD Silicone Scar Gel Dash Topic OTC Dash Topic+ Dermaso

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2023-12-07
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2024-09-12
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-09-18
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2023-09-18

Official Correspondent

Robert Munroe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lindo Manufacturing, 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
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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**
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

Similar Registrations

Registration Number	Establishment Name	Location
2950792	BIODERMIS LLC	Henderson, NV, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3009192857	Neodyne Biosciences, Inc.	Fremont, CA, US
3005857283	PRECO, LLC	Somerset, WI, US
3019769561	ScarPro NV	Aalter Flanders, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023548698. Last updated year: 2026. Please use registration number 3023548698 when referencing this establishment in official correspondence.