Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006785496

FEI Number

3006785496

Entity Name

Laboratorios Biogalenic, S.A. de C.V.

City/State/Country

Soyapango San Salvador, SV

Establishment Address

Calle Claper Blvd. Del Ejercito Nacional km 5.5, Soyapango San Salvador 1639 SV, SV

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Laboratorios Biogalenic Sociedad Anonima de Capital Variable (Owner Number: 10084089)

Owner / Operator Contact Address

Blvd del Ejerc Nac Km 5 1/2 Soyapango, San Salvador, SV-SS 00, SV

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242717

PMA Number

N/A

All Registered Proprietary Names

Sterile Water for Inhalation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2022-01-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-03-12
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2026-01-15
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-02-07

Official Correspondent

No official correspondent registered.

US Agent Details

Herschel Gaddy Business: Herschel J. Gaddy & Associates Email: Herschel.gaddy@gaddyandassociates.com Phone: (816) 2323856

Related Public Records

Same Entity

Laboratorios Biogalenic Sociedad Anonima de Capital Variable

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
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

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

Similar Registrations

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3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH
3011137372	Teleflex Medical LLC	Morrisville, NC, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006785496. Last updated year: 2026. Please use registration number 3006785496 when referencing this establishment in official correspondence.