FOREMOUNT ENTERPRISE CO., LTD.

FDA Device Registration & Listing · Taichung City, TW · Registration 3010402691

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010402691
FEI Number
3010402691
Entity Name
FOREMOUNT ENTERPRISE CO., LTD.
City/State/Country
Taichung City, TW
Establishment Address
No. 257, Sec. 5, Changping Rd., Shengang District, Taichung City 429, TW
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
FOREMOUNT ENTERPRISE CO., LTD. (Owner Number: 9042153)
Owner / Operator Contact Address
No.17, Alley 15, Lane 5,, Shenan Street, Shengang District, Taichung City, TW-TXG 429, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Resuscitator W/Peep Valve PVC Resuscitator and Accessories Manual Resuscitator, BVM Antistatic Silicone Face Mask; Silicone Face Mask Anesthetic mask;EZ mask;Cushion mask; Face mask; Silicone mask; Flexichamber face mask; Anesthesia mask, Rotation Mask Anesthesia Face mask NBR (Nitrile Rubber) glove Introducer Vented Tracheal Tube Introducers (Bougie) Bougie Venturi Mask Large Volume Nebulizer Nasal cannula Pocket size resuscitator Emergency response mask CPR Mask BERMAN AIRWAYS Airway OROPHARYNGEAL DYNACOR AIRWAYS GUEDEL AIRWAYS Ventilator tubing HUMIDIFIER Air Breathing Bag Reservoir Bag Bag NEBULIZER Anesthesia Circuit Anesthesia breathing circuit Anesthesia Circuit Accessories Oxygen tubing HMEF,FILTER Mouth screw Mouth opener Laryngoscope blade Head harness Head Strap

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 2014-02-20
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2018-05-21
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2018-05-21
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2018-05-21
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2000-07-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2014-12-25
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2013-09-13
BYF Mask, Oxygen, Low Concentration, Venturi Anesthesiology Class 1 868.5600 2025-09-18
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2025-01-06
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2009-12-04
CBP Valve, Non-Rebreathing Anesthesiology Class 2 868.5870 2005-09-01
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2005-05-20
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2012-02-09
KFZ Humidifier, Non-Direct Patient Interface (Home-Use) Anesthesiology Class 1 868.5460 2019-09-04
BTC Bag, Reservoir Anesthesiology Class 1 868.5320 2012-07-27
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2020-04-17
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2015-12-11
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2020-08-20
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2020-04-17
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2006-11-14
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2006-01-25
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2006-01-25

Official Correspondent

William Jiang

US Agent Details

Matt Dryden Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

FOREMOUNT ENTERPRISE 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
K812140 3M Company BIRD MEAN AIRWAY PRESSURE MONITOR 1981-08-20
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010402691. Last updated year: 2026. Please use registration number 3010402691 when referencing this establishment in official correspondence.
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