MING FAI INDUSTRIAL (SHENZHEN) CO. LTD.

FDA Device Registration & Listing · SHENZHEN Guangdong, CN · Registration 9710018

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9710018
FEI Number
3003340745
Entity Name
MING FAI INDUSTRIAL (SHENZHEN) CO. LTD.
City/State/Country
SHENZHEN Guangdong, CN
Establishment Address
Ming Fai Industrial Estate, BAINIKENG, PINGHU LONGGANG, SHENZHEN Guangdong 518111, CN
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Ming Fai Enterprise International Co., Ltd. (Owner Number: 9035380)
Owner / Operator Contact Address
Unit D3, 8/F, TML Tower, No 3 Hoi Shing, Tsuen Wan, New Territories, Kowloon, Hong Kong, HK-NOTA -, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Safety Straps Gel Positioners Toothbrush Cotton ball / Cotton pad Probe Covers Bottle Decanter Vial Decanter ADHESIVE BANDAGE Drape Surgical Bag Decanter Knob Covers Equipment Covers (drape /set-up cover) Transfer Device O.R. Table Sheets

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NZD Stretcher, Patient Restraint General Hospital Class 1 880.6900 2010-01-11
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2010-01-11
EFW Toothbrush, Manual Dental Class 1 872.6855 1998-04-30
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2007-12-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-11-06
KPE Container, I.V. General Hospital Class 2 880.5025 2013-11-06
KPE Container, I.V. General Hospital Class 2 880.5025 2013-11-06
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2007-12-21
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2014-05-29
KPE Container, I.V. General Hospital Class 2 880.5025 2013-11-06
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 2017-06-22
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2013-11-06
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-11-06
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2010-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Ming Fai Enterprise International Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007143236 MING FAI ENTERPRISE INTERNATIONAL CO., LTD Kowloon, Hong Kong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0001-2020 The Metrix Company 2
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710018. Last updated year: 2026. Please use registration number 9710018 when referencing this establishment in official correspondence.
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