FDA Registration Number: 3008240989

Last Validated: October 19, 2021

Status: Valid

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

U.S. Agent and Official Correspondent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
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 October 18, 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 October 18, 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
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile NOB Valid October 18, 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 October 18, 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 October 18, 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 October 18, 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
Accessory, Surgical Apparel LYU Valid October 18, 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, Oral Irrigation EFS Valid October 18, 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 October 18, 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)
Respirator, Surgical MSH Valid October 18, 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
Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs) QKU Valid October 18, 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
Joint, Ankle, External Brace ITW Valid October 18, 2021

Device Listing

Device Name

Joint, Ankle, External Brace

Product Code

ITW

Company Function(s)

Foreign Exporter

Proprietary Name(s)

Ankle Buddy
Face Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health Emergency QKR Valid October 18, 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
Polymer Patient Examination Glove LZA Valid October 18, 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
Disinfectant, Medical Devices LRJ Valid October 18, 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
Strip, Temperature, Forehead, Liquid Crystal KPD Valid October 18, 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

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