Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015418903

FEI Number

3015418903

Entity Name

BLUE ECHO CARE

City/State/Country

Portland, OR, US

Establishment Address

3639 SE 21st Ave, Portland, OR 97202, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Blue Echo Care (Owner Number: 10059927)

Owner / Operator Contact Address

21620 SW Stafford Rd, Tualatin, OR 97062, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cleanse Right Ear Wax Remover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRD	Applicator, Ent Drug	Ear, Nose, Throat	Class 1	874.5220	2022-09-07
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-06-05
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2023-02-11
OGQ	Ear Irrigation Kit	General Hospital	Class 1	880.6960	2023-01-10

Official Correspondent

Edward Wagner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Blue Echo Care

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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Similar Registrations

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9613926	Gesco Healthcare Private Limited	CHENNAI, Tamil Nadu, IN
3022555290	Hangzhou Qiantang Longyue Biotechnology Co.,Ltd	Hangzhou Zhejiang, CN
3000184666	OMEGA PLASTICS, INC.	Clinton Township, MI, US
3004530184	ANDERSEN CALEDONIA LTD	Bellshill Scotland, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015418903. Last updated year: 2026. Please use registration number 3015418903 when referencing this establishment in official correspondence.