Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003902679

FEI Number

3003902679

Entity Name

ENTER MEDICAL CORPORATION

City/State/Country

Chiayi County, TW

Establishment Address

No. 66-5, Yao Tzu Chu, Tsai Kung Village, Hsin Kang Township, Chiayi County 61642, TW

Establishment Type(s)

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

Owner / Operator

ENTER MEDICAL CORPORATION (Owner Number: 9054547)

Owner / Operator Contact Address

No.66-5,Yao Tzu Chu, Tsai Kung Village, Hsin Kang Township, Chiayi County, TW-CYQ 61642, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042556

PMA Number

N/A

All Registered Proprietary Names

ShineBall GTC2025 1/2" (Tube) EnterMed Aspirating Tubing Disposable Vacuum Tubing Shine ball Aspirating Tubing Medway Aspirating Tubing GTC2024 3/8 (Tube) ENTER ShineBall ENTER seal rite valve humidifier, non-direct patient interface (home-use) strap, head, gas mask ShineBall ENTER Dive Mask OPTICAL LENS drain, tee (water trap) THE LIFEGUARD set, tubing and support, ventilator (w harness) ShineBall ENTER ShineBall ENTER ENTER OXYGEN MASK Airway Adapter Double Swivel Elbow Connector Catheter Mount and Connectors Oxygen T-piece Catheter Mount PN-500-XX PN-2025-XX Swivel Oxygen Connector PN-2024-XX Oxygen Connector Oxygen Tube Adapter Airway Connector Elbow Connector tubing, pressure and accessories bag, reservoir Endoscopic Bite Block Enter ENTER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2004-06-07
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2004-06-07
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2020-05-14
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2021-10-24
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2021-10-24
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2004-06-07
HPB	Clip, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1410	2024-11-14
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2021-10-24
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2014-05-16
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2021-10-24
KBW	Screw, Oral	Ear, Nose, Throat	Class 1	874.4420	2004-06-07
KAC	Tube, Laryngectomy	Ear, Nose, Throat	Class 1	874.4420	2004-06-07
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2003-01-02
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2025-12-18
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2021-10-24
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2021-10-24
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2018-01-25
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-12-01

Official Correspondent

TSUNG FU KUO

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

ENTER MEDICAL CORPORATION

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-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003902679. Last updated year: 2026. Please use registration number 3003902679 when referencing this establishment in official correspondence.