Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042277801

FEI Number

3042277801

Entity Name

STERIEOSS MEDICAL TECHNOLOGY (XIAMEN) CO., LTD.

City/State/Country

XIAMEN Fujian, CN

Establishment Address

3rd Floor, No.17-2, Hutou Road, Haicang District, No.17-3, Hutou Road, Haicang District, XIAMEN Fujian 361026, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

SteriEOSS Medical Technology (XiaMen) Co., Ltd. (Owner Number: 10094421)

Owner / Operator Contact Address

3rd Floor, No.17-2, Hutou Road, Haicang District, XIAMEN, CN-FJ 361026, CN

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
EXJ	Device, Incontinence, Urosheath Type, Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-11-27

Official Correspondent

Yanting Wang

US Agent Details

weian Huang Email: weian@isosh.com Phone: (949) 4624543

Related Public Records

Same Entity

SteriEOSS Medical Technology (XiaMen) Co., Ltd.

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
K772144	Medline Industries, Inc.	CATHETER, DISP., EXTERNAL, MALE	1977-11-28
K945628	Mentor Corp.	CLEAR ADVANTAGE II	1995-07-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042277801. Last updated year: 2026. Please use registration number 3042277801 when referencing this establishment in official correspondence.