Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010598825

FEI Number

3010598825

Entity Name

ESTERILIZACION S.L

City/State/Country

MONTMELO Barcelona, ES

Establishment Address

STREET VERNEDA DEL CONGOST, NR 12, MONTMELO Barcelona 08160, ES

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

ESTERILIZACION S.L (Owner Number: 10045385)

Owner / Operator Contact Address

Street Verneda del congost, nr.12, Montmelo, ES-B 08160, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2013-11-11

Official Correspondent

Lee Xiong

US Agent Details

Lee Xiong Business: Hartmann USA, INC. Email: lee.xiong@hartmann.info Phone: (800) 9851133

Related Public Records

Same Entity

ESTERILIZACION S.L

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

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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 3010598825. Last updated year: 2026. Please use registration number 3010598825 when referencing this establishment in official correspondence.