Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005711994

FEI Number

3006784768

Entity Name

Coomex Sources Co. Ltd.

City/State/Country

Qingdao City Shandong, CN

Establishment Address

Room 903, Xiwang Tower, #138 Dunhua Rd, Qingdao City Shandong 266034, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Coomex Sources Co. Ltd. (Owner Number: 10023665)

Owner / Operator Contact Address

Room 903, Xiwang Tower, #138 Dunhua Rd, Qingdao, CN-SD 266034, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Endotracheal Tube; Laryngeal Mask Airway Face Shield Sole Angel; Strutz Surgical Mask, Face Mask X-Ray Film Holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2019-06-05
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2020-04-10
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-01-05
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-10
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2007-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Coomex Sources 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Similar Registrations

Registration Number	Establishment Name	Location
3037007211	ARETE MEDICAL DEVICES	Mullica Hill, NJ, US
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3014829416	MCMURRAY MEDICAL	Minneapolis, MN, US
3015314035	Bio-Med Healthcare Products Pvt. Ltd.	Palwal Haryana, IN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005711994. Last updated year: 2026. Please use registration number 3005711994 when referencing this establishment in official correspondence.