Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008281139

FEI Number

3008281139

Entity Name

DANYANG XINYA VALVE CO., LTD.

City/State/Country

Danyang Jiangsu, CN

Establishment Address

No. 12 Dongjin West Road, Yanling Town, Danyang Jiangsu 212341, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Danyang Xinya Valve Co., Ltd. (Owner Number: 10033907)

Owner / Operator Contact Address

No. 12 Dongjin West Road, Yanling Town, Danyang Jiangsu, CN-JS 212341, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oropharyngeal Airway CPAP tubing FLOW METER for Oxygen Concentrator Ear Syringe Protective face mask, KN95 Protective Face Shield Oxygen Connector Oxygen Mask Oxygen tubing Switch, Pressure switch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2023-11-13
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2023-11-13
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	Anesthesiology	Class 1	868.2300	2012-05-07
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2024-11-12
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2012-08-21
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2023-07-19
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2023-05-31
CAM	Yoke Assembly, Medical Gas	Anesthesiology	Class 1	868.6885	2021-03-01
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-18
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2014-08-29
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2023-05-31
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2023-05-31
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2023-11-13
JFE	Valve, Switching (Ploss)	Anesthesiology	Class 1	868.1965	2024-08-01
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2012-05-07

Official Correspondent

Xie Yi

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Danyang Xinya Valve 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
K780365	Spica, Inc.	OXYGEN/NITROUS OXIDE OUTLET	1978-03-30

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

Similar Registrations

Registration Number	Establishment Name	Location
3037007211	ARETE MEDICAL DEVICES	Mullica Hill, NJ, US
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3014829416	MCMURRAY MEDICAL	Minneapolis, MN, US
3015314035	Bio-Med Healthcare Products Pvt. Ltd.	Palwal Haryana, IN
3012002722	PRO-MED (WUXI)IMP.& EXP.CO.,LTD.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008281139. Last updated year: 2026. Please use registration number 3008281139 when referencing this establishment in official correspondence.