Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014507910

FEI Number

3014507910

Entity Name

FC COMPANY LTD

City/State/Country

Hong kong, HK

Establishment Address

Workshop 9 on 15/F Fonda Industrial Building Nos.37-39 Au Pui Wan Street Fo Tan Shatin New Territories. Hong K, Hong kong 999077, HK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FC Company LTD (Owner Number: 10082490)

Owner / Operator Contact Address

Workshop 9 on 15/F Fonda Industrial Building Nos.37-39 Au Pui Wan Street Fo Tan Shatin New Territories. Hong K, Hong kong, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pocket BVM With O2 Tubing Pocket BVM NuMask Pocket BVM Tactical Ventilator, Emergency, Manual (Resuscitator) - Cyclone Pocket BVM Pocket BVM; Pocket BVM Airway

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2021-08-04

Official Correspondent

Francis Chung

US Agent Details

Steven Sonnenberg Business: Overnite Consulting Group, LLC Email: steveisoft@gmail.com Phone: (443) 9296543

Related Public Records

Same Entity

FC Company LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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.

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3010272829	Salter Labs de Mexico de S.A. de C.V.	Chihuahua Mexico, MX
3010402691	FOREMOUNT ENTERPRISE CO., LTD.	Taichung City, TW
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014507910. Last updated year: 2026. Please use registration number 3014507910 when referencing this establishment in official correspondence.