Henan Huibo Medical Co., Ltd.
Manufacturer and brand owner in Nanyang, Henan, China. 17 device types, 6 products catalogued, 1 clearance.
Henan Huibo Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Mask, Scavenging and 15 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
17device types registered with the FDA
6products catalogued under its own name
1510(k) clearance
Registration
| Registered name | HENAN HUIBO MEDICAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012852163 |
| FEI number | 3012852163 |
| DUNS | 560455084 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 河南汇博医疗股份有限公司 |
|---|---|
| Unified social credit code | 91411300767846255L |
| Source | NMPA UDI database |
Location
| City | Nanyang |
|---|---|
| Province | Henan |
| Address | Weishi Road Central, Nanyang New Energy |
| Postal code | 473000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Beads, Hydrophilic, For Wound Exudate Absorption | Class 1 | Foam dressing | 2017 | 7 |
| Disinfectant, Medical Devices | Class 1 | Alchocol Wipes; Disinfecting Hand Gel; Hand Sanitizer; Hand Sanitizer Gel; Hand Sanitizing Wipes; Sanitizing Wipes | 2020 | 197 |
| Dressing, Compression | Class 1 | Compression Bandage | 2019 | 87 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Alginate dressings | 2016 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | hydrocolloid dressings | 2016 | 195 |
| Elastomer, Silicone, For Scar Management | Class 1 | medical silicone sheet dressings, 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, Tetyana Natural Silicone Scar Sheets-1.5″*2.8″, 7 Reusable Sheets, St. Mege Silicone Scar Sheets-5.9”*1.6”,4 Reusable Sheets, Skintensive ScarSmart Scar Sheets 3.5 in*1.6 in and 1 more | 2016 | 85 |
| Expander, Surgical, Skin Graft | Class 1 | medical skin stretching and secure wound closure system | 2016 | 4 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Mask, Face Mask, Nonwoven Face Mask, Medical Disposable Face Mask, KN95 Protective Mask, Daily Respiratory Protective Mask | 2020 | 182 |
| Joint, Ankle, External Brace | Class 1 | Compression Garments | 2019 | 134 |
| Mask, Scavenging | Class 1 | Mask, Face Mask, Nonwoven Face Mask, Medical Disposable face Mask | 2020 | 158 |
| Mask, Surgical | Class 2 | Medical surgical mask, Disposable surgical mask, surgical mask, Mask, Face Mask, Nonwoven Face Mask, Medical Disposable face Mask, Disposable medical surgical mask | 2020 | 125 |
| Non-Surgical Gown | Class 1 | Disposable Nonwoven Isolation Gown; Disposable Nonwoven Protective Clothing | 2020 | 318 |
| Orthosis, Lumbar | Class 1 | waist support, back support | 2019 | 110 |
| Pack, Hot Or Cold, Disposable | Class 1 | Medical Discoloration Cooling Gel Patch | 2023 | 176 |
| Respirator, Surgical | Class 2 | N95 Daily Respiratory Protective Mask N95 Respirator, Respirator, Surgical, Health Care Particulate Respirator and Surgical Mask | 2020 | 118 |
| Silicone Hydrogel For Scar Management | Class 1 | medical silicone gel dressings, LUXROS Scar Gel -25g, TEREZ & HONOR Advanced Silicone Scar Gel-30g, AZALLY Medical Silicone Scar Gel-30g, Aroamas Advanced Medical Silicone Scar Gel-30g,45g, Teeth Whitening Gel and 1 more | 2017 | 22 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | Class 2 | medical compression stockings | 2016 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Huibo Medical | DWL | 4 |
| Huibo Medical | NAC | 4 |
| Huibo Medical | MDA | 3 |
| Huibo Medical | PFP | 2 |
| Huibo Medical | KOZ | 2 |
| Huibo Medical | FZW | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K202842 | 2021-11-26 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Main products | Wound repair products, Scar prevention series, Intelligent rehabilitation equipment, Clinical nutrition food, Infection control and protective equipment |
| Certifications | Internet Pharmaceutical Information Service License |
| Export markets | Belgium and European countries |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.