Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008331339

FEI Number

3008331339

Entity Name

PLASTIFLEX HEALTHCARE DIVISION OF PLASTIFLEX GROUP NV

City/State/Country

Paal Beringen Limburg, BE

Establishment Address

Buntjesstraat 13, Paal Beringen Limburg B-3583, BE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

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

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

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	2016-08-23
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2010-03-26

Official Correspondent

Patricia DuBois

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
3008342612	Dongguan Plastiflex Hose Technology Ltd	Dongguan City Guangdong, CN

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

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 3008331339. Last updated year: 2026. Please use registration number 3008331339 when referencing this establishment in official correspondence.