Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042840696

FEI Number

3042840696

Entity Name

ALERA MEDTECH LLC

City/State/Country

Buckley, WA, US

Establishment Address

159 W Mason Ave, Buckley, WA 98321, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Alera Medtech LLC (Owner Number: 10093693)

Owner / Operator Contact Address

77 Rowe Street, Suite 2C, Auburndale, MA 02466, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SureSet Loop Securement Device SureSet Foley Catheter Securement Device

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	2026-01-05
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2026-04-18

Official Correspondent

Robert Rudelius

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alera Medtech 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
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 3042840696. Last updated year: 2026. Please use registration number 3042840696 when referencing this establishment in official correspondence.