Hynaut Health Technology Co., Ltd.
Registered establishment in Qingdao, Shandong, China. 68 device types.
Hynaut Health Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pad, Eye, Dermatome and 66 other device types. Its earliest product listing with the FDA dates from 2012.
Registration
| Registered name | Hynaut Health Technology Co., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008808560 |
| FEI number | 3004601847 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Qingdao |
|---|---|
| Province | Shandong |
| Address | Jiangshan Industrial Area, Laixi |
| Postal code | 266603 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Ureteral Catheter | Class 1 | adaptor | 2024 | 5 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Swab | 2017 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Hisopo esteril 15 cm cabo madera env. individual | 2026 | 100 |
| Bandage, Elastic | Class 1 | Elastic Bandage,Gauze Bandage | 2012 | 280 |
| Burn Kit Without Drug | Class 1 | Burn kit | 2024 | 3 |
| Cap, Surgical | Class 1 | 2020 | 178 | |
| Catheter, Drainage, Intraoral/Extraoral | Class 1 | Catheter | 2024 | 3 |
| Catheter, Infusion | Class 1 | IV Catheter Guide – Macrodrip Perfusion SET V14, Guia DE Suero – Perfus Macrogotero V14 | 2026 | 8 |
| Catheter, Nasal, Oxygen | Class 1 | nasal catheter | 2024 | 14 |
| Catheter, Nasopharyngeal | Class 1 | Nasopharyngeal Catheter | 2024 | 1 |
| Catheters, Suction, Tracheobronchial | Class 1 | Suctiion catheters | 2024 | 93 |
| Container, Liquid Medication, Graduated | Class 1 | test tube | 2026 | 68 |
| Container, Specimen, Sterile | Class 1 | Plastic Petri Dish 100 x 20 mm, Disposable sterile container with screw cap for biological material (sterile urine culture container), Recipiente esteril descartable c/tapa rosca p/material biologico (recipiente esteril urocultivo), Caja Petri plastica 100 x 20 mm | 2026 | 79 |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | Class 1 | Microtubo tipo Eppendorf base conica por 1.5 ml, Eppendorf type microtube conical bottom 1.5 ml | 2026 | 6 |
| Cotton, Roll | Class 1 | cotton, roll | 2024 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | 2020 | 176 | |
| Depressor, Tongue, Non-Surgical | Class 1 | nasal irrigator | 2024 | 100 |
| Dermatome | Class 1 | Dermatome | 2024 | 6 |
| Disinfectant, Medical Devices | Class 1 | Iodine swab | 2019 | 197 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | dressing | 2024 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Wound Dressing,I.V. Adhesive Dressing | 2017 | 195 |
| Elastomer, Silicone, For Scar Management | Class 1 | elastomer | 2024 | 85 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | C004; C005; C006; C012; C017; C022; C023; C024; KN95 Protective Mask | 2020 | 182 |
| First Aid Kit With Drug | Class N | first aid kit | 2024 | 57 |
| First Aid Kit Without Drug | Class 1 | First aid kit | 2019 | 132 |
| Floss, Dental | Class 1 | Floss pick | 2019 | 151 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze Pad, Underpad, Cotton balls | 2018 | 266 |
| Holder, Ureteral Catheter | Class 1 | holder | 2024 | 29 |
| Kit, First Aid, Talking | Class 1 | first aid kit | 2024 | 18 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | HCG Test Strip | 2021 | 30 |
| Mask, Gas, Anesthetic | Class 1 | mask | 2024 | 71 |
| Mask, Oxygen | Class 1 | mask | 2024 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | mask | 2024 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | mask | 2024 | 72 |
| Mask, Scavenging | Class 1 | disposable mask | 2020 | 158 |
| Mask, Surgical | Class 2 | Surgical Mask | 2021 | 125 |
| Maternity Kit | Class 1 | maternity kit | 2024 | 2 |
| Mouthguard, Over-The-Counter | Class U | Face Mask | 2018 | 4 |
| Nasal Spray, Ent Delivery | Class 1 | nasal spray | 2024 | 23 |
| Needle, Aspiration And Injection, Disposable | Class 1 | Surgical Needle – Meghini Type – Specification 16G X 5″, Disposable needle 25/8 Terumo (21 G) | 2026 | 37 |
| Needle, Suturing, Disposable | Class 1 | Aguja Quirurgica – Tipo Descartable – Especificacion 40/8 – Unidad Venta C/U, Aguja Quirurgica – Tipo Descartable – Especificacion 25/8 – Unidad Venta C/U | 2026 | 21 |
| Non-Surgical Gown | Class 1 | 2020 | 318 | |
| Nursing Pad, Cohesive Gel | Class 1 | nursing pad | 2024 | 9 |
| Nursing Pad, Hydrogel | Class 1 | nursing pad, hydrogel | 2024 | 15 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | Class 1 | nursing pad | 2024 | 48 |
| Pack, Hot Or Cold, Disposable | Class 1 | Warm Patch, Cold Pack, Cool Patch, Fever Relief Patch, Cool gel, Freeze gel | 2012 | 176 |
| Pad, Alcohol, Device Disinfectant | Class U | One+Step® Alcohol Prep Pads, Hynaut Alcohol Prep Pads, Alcohol Wipes, Alcohol prep pad | 2018 | 49 |
| Pad, Eye | Class 1 | tips and pads | 2024 | 100 |
| Pad, Kelly | Class 2 | pad | 2024 | 5 |
| Pad, Menstrual, Intralabial | Class 1 | pad | 2024 | 2 |
| Pad, Menstrual, Reusable | Class 1 | menstrual pad | 2024 | 31 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | Class 1 | menstrual pad | 2024 | 29 |
| Pad, Menstrual, Unscented | Class 1 | menstrual Pad | 2024 | 132 |
| Patient Examination Glove | Class 1 | 2020 | 6 | |
| Personal Protection Kit | Class 1 | Disposable Vinyl Gloves , Disposable Nitrile Gloves | 2020 | 8 |
| Radiographic Protective Glove | Class 1 | Disposable Vinyl Gloves , Disposable Nitrile Gloves | 2020 | 30 |
| Scissors, Wire Cutting, Ent, Non-Sterile | Class 1 | Scissors | 2024 | 2 |
| Scissors, Wire Cutting, Ent, Sterile | Class 1 | Scissors | 2024 | 1 |
| Sheet, Burn | Class 1 | sheet | 2024 | 20 |
| Shield, Protective, Personnel | Class 1 | Face Shield | 2021 | 78 |
| Silicone Hydrogel For Scar Management | Class 1 | Silicone Hydrogel | 2024 | 22 |
| Sprays, Synthetic, Smear | Class 1 | sprays, synthetic, smear | 2024 | 3 |
| Strap, Head, Gas Mask | Class 1 | strap | 2024 | 29 |
| Stylet, Ureteral | Class 1 | ureteral stylet | 2024 | 2 |
| Tape And Bandage, Adhesive | Class 1 | Medical Tape, Adhesive Bandage, Wound Plaster | 2012 | 353 |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | Class 1 | Bandage | 2024 | 13 |
| Tips And Pads, Cane, Crutch And Walker | Class 1 | eye pad | 2024 | 69 |
| Tourniquet, Nonpneumatic | Class 1 | tourniquet | 2024 | 124 |
Clearances
No clearance names Hynaut Health Technology Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210218 | 2021-05-07 | FXX | Traditional | Qingdao Hainuo Biological Engineering Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 2000+ |
|---|---|
| Factory area | 350,000+ square meters |
| Main products | Medical face masks, KN95 masks, Alcohol & iodine wipes, Isolation gowns, Infrared thermometers |
Nearby Manufacturers
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.