Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015515504

FEI Number

3015515504

Entity Name

DONGGUAN RONGRUI-CENTURY SCIENCE&TECHNOLOGY CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Taoyuan Road #1, Room #101, Building #5, Songshan Lake Ind.Dev Zone, Dongguan Guangdong 523808, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan Rongrui-Century Science&Technology Co., Ltd (Owner Number: 10060464)

Owner / Operator Contact Address

Taoyuan Road #1, Room #101, Building #5, Songshan Lake Ind.Dev Zone,, Dongguan, CN-GD 523808, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medicine Chamber Spacer RVC002 RVC001 Breathing Tube RVTB002 Breathing Tube RVTB001 ETCO2 Nasal Cannula RVL008 Nose L; ETCO2 Nasal Cannula RVL006 Oral-nose M; ETCO2 Nasal Cannula RVL008 Oral-nose M; ETCO2 Nasal Cannula RVL008 Oral-nose L; ETCO2 Nasal Cannula RVL008 Nose S; NASAL CANNULA RVH001L; NASAL CANNULA RVL001L; NASAL CANNULA RVL001M; NASAL CANNULA RVL001S ETCO2 Nasal Cannula RVL006 Nose S; ETCO2 Nasal Cannula RVL006 Nose M; ETCO2 Nasal Cannula RVL006 Oral-nose L; ETCO2 Nasal Cannula RVL006 Oral-nose S; ETCO2 Nasal Cannula RVL008 Oral-nose S; ETCO2 Nasal Cannula RVL006 Nose L; ETCO2 Nasal Cannula RVL008 Nose M;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EPN	Pump, Nebulizer, Manual	Ear, Nose, Throat	Class 1	874.5220	2025-06-30
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2023-02-26
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-11-24

Official Correspondent

Jasen Zhang

US Agent Details

Mr Paul Email: conruimedical@gmail.com Phone: (678) 7790799

Related Public Records

Same Entity

Dongguan Rongrui-Century Science&Technology 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 3015515504. Last updated year: 2026. Please use registration number 3015515504 when referencing this establishment in official correspondence.