Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616518

FEI Number

3002600322

Entity Name

LABORATORIOS JALOMA, S.A. DE C.V.

City/State/Country

GUADALAJARA Jalisco, MX

Establishment Address

AQUILES SERDAN NO. 438, GUADALAJARA Jalisco 44380, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LABORATORIOS JALOMA, S.A. DE C.V. (Owner Number: 9042482)

Owner / Operator Contact Address

AQUILES SERDAN NO. 438, --, GUADALAJARA, JALISCO, MX-NOTA 44380, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LABORATORIOS JALOMA, S.A. DE C.V., LABORATORIOS JALOMA, S.A. DE C.V., LABORATORIOS JALOMA, S.A. DE C.V.,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2004-11-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2000-08-09
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2000-08-09

Official Correspondent

Bo Burge

US Agent Details

BO BURGE Burge Business: BBI INTERNATIONAL INC. Email: bo@bbinternationalfda.com Phone: (956) 7234826

Related Public Records

Same Entity

LABORATORIOS JALOMA, S.A. DE C.V.

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

Registration Number	Establishment Name	Location
3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3014553350	CORRECT BREATHING CONCEPTS, LLC	Painesville, OH, US
3023122974	MBET HEALTH, LLC	Tarzana, CA, US
3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616518. Last updated year: 2026. Please use registration number 9616518 when referencing this establishment in official correspondence.