Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010957755

FEI Number

3010957755

Entity Name

NON-CHANGE ENTERPRISE CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

6F.-11, No.12, Ln.609, Sec.5,, Chongxin Rd., Sanchong Dist.,, New Taipei City 24159, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

NON-CHANGE ENTERPRISE CO., LTD. (Owner Number: 10061014)

Owner / Operator Contact Address

6F.-11, No.12, Ln.609, Sec.5,, Chongxin Rd., Sanchong Dist.,, New Taipei City, Taipei, Taiwan, TW-NWT 24159, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Umbilical Cord Clamp Venturi Mask Kit Simple Oxygen Mask Jaw Spreader Non-rebreathing Mask Oxygen T-Piece Nasal Cannula Naso Airway Anesthesia Breathing Circuit with accessories(single-use & reusable) Breathing Bag(latex, latex-free, reusable) Catheter Mount(single-use & reusable) Ventilator Breathing Circuit with accessories(single-use & reusable) Oropharyngeal Airway (Guedel & Berman Airway) HME Anesthesia Mask(single-use & reusable)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2019-07-30
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2019-07-30
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2019-07-30
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2019-07-30
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2019-07-30
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2019-07-30
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2019-07-30
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2019-07-30
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2019-07-30
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2019-07-30

Official Correspondent

House Chen

US Agent Details

Jordan Elder Email: j.elder@rcainc.com Phone: (812) 3437999

Related Public Records

Same Entity

NON-CHANGE ENTERPRISE 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

Similar Registrations

Registration Number	Establishment Name	Location
3000268902	IMPERIAL TRADING LIMITED	Bridgetown Saint Michael, BB
1921846	Cardinal Health	Hazelwood, MO, US
3006638824	ETHICON, INC.	CIUDAD JUAREZ Chihuahua, MX
3005621808	ANJI HONGDE MEDICAL PRODUCTS CO., LTD.	HUZHOU Zhejiang, CN
3006673317	Conod Medical Co.,Limited	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010957755. Last updated year: 2026. Please use registration number 3010957755 when referencing this establishment in official correspondence.