Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021091708

FEI Number

3021091708

Entity Name

AP Services de Mexico, S. De R.L. De C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Blvd Insurgentes, No. 20545, Tijuana Baja California 22234, MX

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

ClimateLine 11

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-12-06

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
3008331339	PLASTIFLEX HEALTHCARE DIVISION OF PLASTIFLEX GROUP NV	Paal Beringen Limburg, BE
3008342612	Dongguan Plastiflex Hose Technology Ltd	Dongguan City Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Similar Registrations

Registration Number	Establishment Name	Location
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
3013505405	BMC (Tianjin) Medical Co., Ltd.	Wuqing District Tianjin, CN
3033530343	BMC INVESTMENT HOLDING LIMITED	Hong Kong, HK
3017684630	ResMed Asia Pte. Ltd.	Singapore South West, SG
3042507287	3B MEDICAL INC	W Jefferson, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021091708. Last updated year: 2026. Please use registration number 3021091708 when referencing this establishment in official correspondence.