Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006897516

FEI Number

3006897516

Entity Name

AOK Tooling Limited

City/State/Country

Shen Zhen Guangdong, CN

Establishment Address

101 and 1Building, 2Building, 3Building, 4Building, 5Building,, NO. 8 of Long Tian No. 3 Road, Long Tian Community, Long Tian Street, Ping Shan District,, Shen Zhen Guangdong 518122, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AOK Tooling Limited (Owner Number: 10024686)

Owner / Operator Contact Address

Flat 2009, 20/F Kowloon Plaza,, No.485, Castle Peak Road, Cheung Sha Wan, Kowloon, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Set Tubing and Support Ventilator AOK 95A Medical Mask (20200049) Professional Respirator 3D N95 (20160001) Professional Respirator 3D N95 B (20180022) VFold Professional Respirator N95 Ti (20180009) VFold Professional Respirator N95 (20170001) VFold Professional Respirator N95 B (20180016) M. Mask (20180021-L) Professional Respirator 3D N95 OR (20100032) V Fold N95 Mask (20190016) Hi-Ox Mask Aerosol Adapter Plain Surgical Face Mask (20190019) Neo-Verso Y CSC300 NOxFLOW sensor for use with NOxBOXi system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2008-02-19
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-07-28
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-05-15
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2013-05-23
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-09-08
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2009-07-16
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2023-03-01

Official Correspondent

Jerry Teng

US Agent Details

Matthew Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

AOK Tooling Limited

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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
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-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
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

Similar Registrations

Registration Number	Establishment Name	Location
3027221819	MAGNAMED MEDICAL TECHNOLOGY	Fort Lauderdale, FL, US
3011971979	HAMILTON CENTRAL EUROPE	Giarmata Timis, RO
3014766741	Hamilton Medical AG	Domat / Ems Graubunden, CH
3015277818	HANGZHOU WEIZE IMP & EXP CO., LTD	Hangzhou Zhejiang, CN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006897516. Last updated year: 2026. Please use registration number 3006897516 when referencing this establishment in official correspondence.