Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010515776

FEI Number

3010515776

Entity Name

NINGBO BOYA MEDICAL EQUIPMENT CO.,LTD.

City/State/Country

Yuyao Zhejiang, CN

Establishment Address

No.102,Jingsan Road,Yaobei Industry Zone, Shaoxiang Village,Langxia Street, Yuyao Zhejiang 315400, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

NINGBO BOYA MEDICAL EQUIPMENT CO.,LTD. (Owner Number: 10045130)

Owner / Operator Contact Address

No.102,Jingsan Road,Yaobei Industry Zone, Shaoxiang Village,Langxia Street, Yuyao, CN-ZJ 315400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NOSE CLIP BY-GL-1(F) BY-GL-1(B) Anesthesia breathing circuit BY-GL-C-1(A) BY-GL-E-1 BY-GL-A-5 BY-GL-C-2(A) BY-GL-A-1(A) BY-GL-1(D) BY-GL-A-5(A) BY-GL-A-3(A) BY-GL-A-1 BY-GL-1(E) BY-GL-A-4 BY-GL-1(C) BY-GL-A-2 BY-GL-A-2(A) BY-GL-C-2 BY-GL-1(A) BY-GL-A-4(A) BY-GL-A-3 BY-GL-C-1 MOUTHPIECE Endoscopic Bite Block Operating light handle cover BY-PT-2 BY-PT-1 BY-PT-3 BY-GL-5 BY-GL-4 BY-GL-3 BY-RGB-P-1 BY-RGB-P-2 HME(Artificial Nose) BY-5 BY-1 BY-4 BY-RGB-P-3 BY-GL-1 BY-GL-2 BY-3 BY-2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2017-10-20
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2013-10-22
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2019-10-28
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2013-11-13
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-10-22
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2013-10-22

Official Correspondent

Zhongyi Wang

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

NINGBO BOYA MEDICAL EQUIPMENT CO.,LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010515776. Last updated year: 2026. Please use registration number 3010515776 when referencing this establishment in official correspondence.