Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007127332

FEI Number

3007127332

Entity Name

HANGZHOU SHANYOU MEDICAL EQUIPMENT CO.,LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No. 138, Louta Development Zone, Guancun Village, Louta Town, Xiaoshan District, Hangzhou Zhejiang 311266, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Shanyou Medical Equipment Co., LTD (Owner Number: 10026601)

Owner / Operator Contact Address

No. 138, Louta Development Zone, Guancun Village, Louta Town, Xiaoshan District,, Hangzhou, CN-ZJ 311266, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd. Hangzhou Shanyou Medical Equipment Co., Ltd.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2011-07-05
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2009-12-30
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2011-07-05
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2008-08-04
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2011-07-05
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-27
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2009-12-30
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2016-08-26
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2011-07-05
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2009-12-30
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2009-12-30
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2011-07-05

Official Correspondent

Yu BaiMing

US Agent Details

Jane Chen Business: Legend Medical Devices, Inc Email: Superiorsupplyusa@gmail.com Phone: (626) 3509733

Related Public Records

Same Entity

Hangzhou Shanyou Medical Equipment 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007127332. Last updated year: 2026. Please use registration number 3007127332 when referencing this establishment in official correspondence.