Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012852163

FEI Number

3012852163

Entity Name

HENAN HUIBO MEDICAL CO., LTD

City/State/Country

Nanyang City Henan, CN

Establishment Address

Weishi Road Central, Nanyang New Energy, Economic & Technological Devlopment Zone, Nanyang City Henan 473000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Henan Huibo Medical CO., LTD (Owner Number: 10053214)

Owner / Operator Contact Address

Weishi Road Central, Nanyang New Energy, Economic & Technological Devlopment Zone, Nanyang City, CN-HA 473000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

medical silicone sheet dressings Tetyana Natural Silicone Scar Sheets-1.5"*2.8", 7 Reusable Sheets Puriderma Medical Silicone Scar Removal Sheets-1.6in*3 in,5 Reusable Sheets;5.9in*1.6 in,4 Reusable Sheets Aroamas Silicone Scar Removal Sheets-3in*1.6 in,8 Reusable Sheets,3in*1.6 in, 4 Reusable Sheets, 5.9in*1.6 in,4 Reusable St. Mege Silicone Scar Sheets-5.9''*1.6'',4 Reusable Sheets Skintensive ScarSmart Scar Sheets 3.5 in*1.6 in Zissa SILICONE SCAR SHEETS- starter kit-5 Sheets: 6.3" x 1.5", replenishment kit-3 Sheets: 6.3" x 1.5" Disposable surgical mask, surgical mask Mask, Face Mask, Nonwoven Face Mask, Medical Disposable face Mask Disposable medical surgical mask waist support, back support medical silicone gel dressings LUXROS Scar Gel -25g TEREZ & HONOR Advanced Silicone Scar Gel-30g Aroamas Advanced Medical Silicone Scar Gel-30g,45g AZALLY Medical Silicone Scar Gel-30g Teeth Whitening Gel Skintensive ScarSmart Scar Gel-45g Compression Garments Disposable Nonwoven Isolation Gown; Disposable Nonwoven Protective Clothing KN95 Protective Mask, Daily Respiratory Protective Mask Mask, Face Mask, Nonwoven Face Mask, Medical Disposable Face Mask Compression Bandage Respirator, Surgical, Health Care Particulate Respirator and Surgical Mask N95 Daily Respiratory Protective Mask N95 Respirator Foam dressing Mask, Face Mask, Nonwoven Face Mask, Medical Disposable face Mask hydrocolloid dressings Alginate dressings medical skin stretching and secure wound closure system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2016-11-10
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-12-31
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2019-12-11
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2017-03-31
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-11-01
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-20
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-06
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2019-11-01
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-02-26
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	General, Plastic Surgery	Class 1	878.4018	2017-03-31
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-02-26
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-11-10
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2016-11-10
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2016-11-10

Official Correspondent

Boyle Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Henan Huibo Medical CO., LTD

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012852163. Last updated year: 2026. Please use registration number 3012852163 when referencing this establishment in official correspondence.