Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008261717

FEI Number

3008261717

Entity Name

XIAMEN COMPOWER MEDICAL TECH. CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

Unit 301, No. 16 Xianghong Road, Xiamen Fujian 361115, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Xiamen Compower Medical Tech. Co., Ltd. (Owner Number: 10031696)

Owner / Operator Contact Address

Unit 301, No.16, Xianghong Road,, Xiang' An Torch Industrial Zone,, Xiamen, CN-FJ 361101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210723

PMA Number

N/A

All Registered Proprietary Names

Collar,Adjustable Collars, Fixed Collars Oropharyngeal Airway Vinyl patient exam gloves powder free Anesthesia mask CPR Mask with Oxygen Port Non-Rebreathing Valve (18.5mm) CPR Mask without Oxygen Port Non-Rebreathing Valve (15mmOD) Infant CPR Mask with Oxygen Port Cardiopulmonary Resuscitation Aid Kit, with CPR Mask Polymer patient examination glove

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2022-06-30
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2012-04-10
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2023-11-23
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2010-03-01
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2017-12-06
OEV	Cardiopulmonary Resuscitation Aid Kit	Anesthesiology	Class 2	868.5915	2017-12-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-11-24

Official Correspondent

Lifen Chen

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Xiamen Compower Medical Tech. 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
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05
K131340	Made Plastic Co., Ltd.	POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES	2014-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
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
3031583032	NINGBO LANDING TECHNOLOGY COMPANY CO., LTD.	Ningbo Zhejiang, CN
2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
3010260768	VTS ONE MEMBER CO., Ltd.	Hai Phong City, VN
3011556461	COMFORT PLUS CORPORATION	New Taipei City, TW
3017297225	BSN Medical GmbH	Hamburg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008261717. Last updated year: 2026. Please use registration number 3008261717 when referencing this establishment in official correspondence.