Medical Device Registration

Valid2021 U.S. FDA Medical Device Establishment Registration

Creative Concepts Manufacturing Ltd.

Establishment Information

Suite F 2, 3rd Floor, Hang Fung Industrial Building , Phase 2

Kowloon, Hong Kong, CN none

852-27-73-6401

charles.fong@creativeconceptsmfg.net

http://www.creativeconceptsmfg.net

U.S. Agent and Official Correspondent

Registrar Corp

144 Research Drive

Hampton VA, USA 23666

+1-757-224-0177

info@registrarcorp.com

www.registrarcorp.com

Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name	Product Code	Status	Last Validated
Mask, Surgical	FXX	Valid	August 02, 2021	Device Listing Device Name Mask, Surgical Product Code FXX Company Function(s) Manufacturer, Foreign Exporter, Repackager/Relabeler Proprietary Name(s) Medical 3 ply mask Disposable protective mask Medical / Surgical 3 ply mask Disposable Mask;
Non-Surgical Isolation Gown	OEA	Valid	August 02, 2021	Device Listing Device Name Non-Surgical Isolation Gown Product Code OEA Company Function(s) Repackager/Relabeler, Foreign Exporter, Manufacturer Proprietary Name(s) Disposable protective cloth, Isolation Gown, Protective Clothing Coverall, Non-Surgical Gown, Non-woven Isolation Gown
Accessory, Surgical Apparel	LYU	Valid	August 02, 2021	Device Listing Device Name Accessory, Surgical Apparel Product Code LYU Company Function(s) Foreign Exporter, Manufacturer, Repackager/Relabeler Proprietary Name(s) Ear Loop Face Mask Disposable Mask Surgical Apparel Non Woven Face Mask
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	NOB	Valid	August 02, 2021	Device Listing Device Name Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile Product Code NOB Company Function(s) Foreign Exporter Proprietary Name(s) Germ Gone
Protector, Skin Pressure	FMP	Valid	August 02, 2021	Device Listing Device Name Protector, Skin Pressure Product Code FMP Company Function(s) Foreign Exporter Proprietary Name(s) Shoe Bite Saver - Shoe Protection Insert
Insoles, Medical	KYS	Valid	August 02, 2021	Device Listing Device Name Insoles, Medical Product Code KYS Company Function(s) Foreign Exporter Proprietary Name(s) Cloud Comfort Heel Cushions Memory Foam Soft Step
Thermometer, Electronic, Clinical	FLL	Valid	August 02, 2021	Device Listing Device Name Thermometer, Electronic, Clinical Product Code FLL Company Function(s) Manufacturer, Repackager/Relabeler, Foreign Exporter Proprietary Name(s) Electronic thermometer (With/Without probe cover) Non-contact Infrared Thermometer ARC Thermometer with probe covers
Respirator, Surgical	MSH	Valid	August 02, 2021	Device Listing Device Name Respirator, Surgical Product Code MSH Company Function(s) Repackager/Relabeler, Foreign Exporter, Manufacturer, Remanufacturer Proprietary Name(s) NIOSH Particulate Respirator Surgical N95 Respirator Particulate Respirator Disposable protective mask N95 Respirator KN95 Mask
Unit, Oral Irrigation	EFS	Valid	August 02, 2021	Device Listing Device Name Unit, Oral Irrigation Product Code EFS Company Function(s) Foreign Exporter Proprietary Name(s) Hydro Blast Pro
Sunglasses (Non-Prescription Including Photosensitive)	HQY	Valid	August 02, 2021	Device Listing Device Name Sunglasses (Non-Prescription Including Photosensitive) Product Code HQY Company Function(s) Foreign Exporter Proprietary Name(s) Smart HD View Sunglasses Sound Shades ( Bluetooth Speaker Sunglasses)
Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)	QKU	Valid	August 02, 2021	Device Listing Device Name Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs) Product Code QKU Company Function(s) Contract Manufacturer, Foreign Exporter, Manufacturer, Repackager/Relabeler Proprietary Name(s) KN95 No. 02676 Medi Concepts KN95 KN95 Protective Respirator Medi Concepts EUA Respirator
Polymer Patient Examination Glove	LZA	Valid	August 02, 2021	Device Listing Device Name Polymer Patient Examination Glove Product Code LZA Company Function(s) Foreign Exporter, Contract Manufacturer, Repackager/Relabeler Proprietary Name(s) Medical use Nitrile Gloves Disposable Nitrile Examination Gloves Powder Free Nitrile Examination Gloves
Joint, Ankle, External Brace	ITW	Valid	August 02, 2021	Device Listing Device Name Joint, Ankle, External Brace Product Code ITW Company Function(s) Foreign Exporter Proprietary Name(s) Ankle Buddy
Strip, Temperature, Forehead, Liquid Crystal	KPD	Valid	August 02, 2021	Device Listing Device Name Strip, Temperature, Forehead, Liquid Crystal Product Code KPD Company Function(s) Remanufacturer, Repackager/Relabeler, Foreign Exporter Proprietary Name(s) Strip, Temperature, Forehead, Liquid Crystal Non-contact thermometer
Disinfectant, Medical Devices	LRJ	Valid	August 02, 2021	Device Listing Device Name Disinfectant, Medical Devices Product Code LRJ Company Function(s) Manufacturer, Remanufacturer, Repackager/Relabeler, Foreign Exporter Proprietary Name(s) Disinfectant, Wipes & Gel Disinfectant, medical devices
Face Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health Emergency	QKR	Valid	August 02, 2021	Device Listing Device Name Face Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health Emergency Product Code QKR Company Function(s) Foreign Exporter, Manufacturer, Contract Manufacturer, Repackager/Relabeler Proprietary Name(s) Disposable Mask; Disposable protective mask, Nonwoven disposable facemask

FDA Registration Number: 3008240989

Last Validated: August 03, 2021

Status: Valid

Valid2021 U.S. FDA Medical Device Establishment Registration

Creative Concepts Manufacturing Ltd.

Establishment Information

U.S. Agent and Official Correspondent

Listings on file with FDA

Valid2021 U.S. FDA Medical Device Establishment Registration

Creative Concepts Manufacturing Ltd.

Establishment Information

U.S. Agent and Official Correspondent

Listings on file with FDA

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