Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016458361

FEI Number

3016458361

Entity Name

SHAOXING REBORN MEDICAL DEVICES CO.,LTD

City/State/Country

Shaoxing Zhejiang, CN

Establishment Address

1F, Building No.6, Medical Devices Industrial Park, No.21, Haitian Road, Binhai New Area, Shaoxing Zhejiang 312366, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shaoxing Reborn Medical Devices Co.,Ltd (Owner Number: 10062255)

Owner / Operator Contact Address

1F, Building No.6, Medical Devices Industrial Park, No.21, Haitian Road, Binhai New Area, Shaoxing, CN-ZJ 312366, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Respiratory exerciser Disposable Nebulizer Mask Disposable Anesthesia Mask Disposable Face Mask Reborn RB-10-02 Disposable Breathing Circuit Disposable Guedel Airway Disposable Closed Suction Catheter Disposable Breathing Bag Disposable Anesthesia Circuit, Disposable Anesthesia Breathing Circuit Disposable Catheter Mount

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2024-03-26
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2020-01-04
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2020-01-04
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-27
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2020-01-04
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2020-01-04
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2020-01-04
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2020-01-04
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2020-01-04
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2020-01-04

Official Correspondent

Wei Xu

US Agent Details

Yin Cheng Email: Usmethod@Foxmail.com Phone: (718) 4758261

Related Public Records

Same Entity

Shaoxing Reborn Medical Devices 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-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

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3029303083	STRIDELINK INC.	Atlanta, GA, US
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3041680548	XRHEALTH AMERICA INC	Needham, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016458361. Last updated year: 2026. Please use registration number 3016458361 when referencing this establishment in official correspondence.