Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612374

FEI Number

3002806674

Entity Name

CHEEN HOUNG ENT. CO. LTD.

City/State/Country

SHULIN Taipei, TW

Establishment Address

23, ALLEY 11, LANE 65, SAN DREEN ST.,, SHULIN Taipei 23805, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

CHEEN HOUNG ENT. CO. LTD. (Owner Number: 8043061)

Owner / Operator Contact Address

23, ALLEY 11, LANE 65, SAN DREEN ST.,, TAIPEI (SHULIN), TW-NOTA 23805, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pocket Mask Face Cradle CPR bag accessory(LiteSaver) 22/10mm Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2015-11-10
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2012-02-14
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2015-02-09
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2025-09-30

Official Correspondent

JAY WANG

US Agent Details

Jessica LeeChen Email: jessicaleechen@yahoo.com Phone: (734) 6297552

Related Public Records

Same Entity

CHEEN HOUNG ENT. 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
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

Similar Registrations

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3014527907	WORLD SOURCE SIMPLE LLC.	Lima, OH, US
3004993040	LAERDAL MEDICAL (SUZHOU) CO., LTD.	215009 SUZHOU JIANGSU PROVINCE, CN
3013226	NORMED	SEATTLE, WA, US
2183615	LIFE CORPORATION	Orlando, FL, US
8030673	PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.	MEXICALI Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612374. Last updated year: 2026. Please use registration number 9612374 when referencing this establishment in official correspondence.