Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015191173

FEI Number

3015191173

Entity Name

EXIN MEDICAL TECHNOLOGY COMPANY, LLC

City/State/Country

Katy, TX, US

Establishment Address

2106 Scarlet Thistle Court, Katy, TX 77494, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Exin Medical Technology Company, LLC (Owner Number: 10059125)

Owner / Operator Contact Address

2106 scarlet thistle cr, Katy, TX 77494, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasal cannula Reservoir bag/ Rebreathing bag Mouth opener HMEF CPR face shield Aerosol mask Pressure Infusor Bag Anesthesia mask/ Cushion mask/ Silicone mask Humidifier Oxygen tubing Airway Ventilator tubing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2022-07-21
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2022-07-21
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2022-07-21
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2022-07-21
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2022-07-21
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2022-07-21
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2022-07-21
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2022-07-21
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2022-07-21
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2022-07-21
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2022-07-21
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2022-07-21

Official Correspondent

Frank Chiang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Exin Medical Technology Company, LLC

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
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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

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3015084765	GUANG DONG EDA TECHNOLOGY CO., LTD.	Dongguan City Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015191173. Last updated year: 2026. Please use registration number 3015191173 when referencing this establishment in official correspondence.