Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008342612

FEI Number

3008342612

Entity Name

Dongguan Plastiflex Hose Technology Ltd

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

Qiaozi Industrial District, Changping Town, Dongguan City Guangdong 523752, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Plastiflex Healthcare Division of Plastiflex Group NV (Owner Number: 10031967)

Owner / Operator Contact Address

Buntjesstraat 13, Paal Beringen, BE-VLI B-3583, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TUB06HPR Heated CPAP Tube Hybernite RT 3000 (Dual Limb), HEN12041BT1PRWGK Hybernite RT 2100 (Single Limb), HFN15023BT1SSWGK Hybernite RT 3100 (Single Limb), HFN12025BT1PRWGK Hybernite RT 1100 (Single Limb), HFN19022BT1SSWGK Hybernite RT 1000 (Dual Limb), HEN19038BT1SSWGK Hybernite RT 2000 (Dual Limb), HEN15040BT1SSWGK Hybernite RT 114 Convenience kit HFN19022BT1STWGO Heater, breathing system W/WO controller (not humidifier or nebulizer)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2022-02-07
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2016-08-23
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2026-01-16
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2026-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Plastiflex Healthcare Division of Plastiflex Group NV

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021091708	AP Services de Mexico, S. De R.L. De C.V.	Tijuana Baja California, MX
3008331339	PLASTIFLEX HEALTHCARE DIVISION OF PLASTIFLEX GROUP NV	Paal Beringen Limburg, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Similar Registrations

Registration Number	Establishment Name	Location
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
9710644	WESTMED de Mexico, S.A de C.V.	Tecate Baja California, MX
8030673	PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.	MEXICALI Baja California, MX
3023272766	CEVA LOGISTICS LIMITED	Daventry Northamptonshire, GB
3014766741	Hamilton Medical AG	Domat / Ems Graubunden, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008342612. Last updated year: 2026. Please use registration number 3008342612 when referencing this establishment in official correspondence.