Data / Medical devices / China / Hynaut Health Technology Co., LTD.
Hynaut Health Technology Co., LTD.: FDA-registered device maker in Qingdao Shandong, China, 1 510(k) clearance
Hynaut Health Technology Co., LTD. is registered with the FDA (registration 3008808560) in Qingdao Shandong, China. It lists 68 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 7, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008808560
- FEI number
- 3004601847
- Address
- Jiangshan Industrial Area, Laixi, Qingdao Shandong, China, 266603
- Owner or operator
- Hynaut Health Technology Co., LTD. (10040387)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- April 9, 2012
- Registered through
- 2026
- Brand names listed
- AGUJA QUIRURGICA - TIPO DESCARTABLE - ESPECIFICACION 25/8 - UNIDAD VENTA C/U, AGUJA QUIRURGICA - TIPO DESCARTABLE - ESPECIFICACION 40/8 - UNIDAD VENTA C/U, Alcohol Wipes, Alcohol prep pad, Bandage, Burn kit, C004; C005; C006; C012; C017; C022; C023; C024; KN95 Protective Mask, Caja Petri plastica 100 x 20 mm, Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Adaptor, Ureteral Catheter | EYI | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Burn Kit Without Drug | OJJ | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Drainage, Intraoral/Extraoral | OAJ | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Infusion | JCY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter, Nasal, Oxygen | BZB | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Nasopharyngeal | ENW | 1 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Manufacturer | accessdata.fda.gov |
| Dermatome | GFD | 1 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Manufacturer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Manufacturer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Ureteral Catheter | EYJ | 1 | Manufacturer | accessdata.fda.gov |
| Kit, First Aid, Talking | OVR | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Maternity Kit | PVT | 1 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Manufacturer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Nursing Pad, Cohesive Gel | NXH | 1 | Manufacturer | accessdata.fda.gov |
| Nursing Pad, Hydrogel | NTC | 1 | Manufacturer | accessdata.fda.gov |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Manufacturer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Kelly | FNW | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Intralabial | NUR | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Reusable | NUQ | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer | accessdata.fda.gov |
| Patient Examination Glove | FMC | 1 | Manufacturer | accessdata.fda.gov |
| Personal Protection Kit | PXC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Radiographic Protective Glove | IWP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scissors, Wire Cutting, Ent, Non-Sterile | NNU | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Wire Cutting, Ent, Sterile | JYA | 1 | Manufacturer | accessdata.fda.gov |
| Sheet, Burn | FPY | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Silicone Hydrogel For Scar Management | PFP | 1 | Manufacturer | accessdata.fda.gov |
| Sprays, Synthetic, Smear | IFI | 1 | Manufacturer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Manufacturer | accessdata.fda.gov |
| Stylet, Ureteral | EYA | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | 1 | Manufacturer | accessdata.fda.gov |
| Tips And Pads, Cane, Crutch And Walker | INP | 1 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| May 7, 2021 | K210218 | SURGICAL MASK, Model Name:C015 | FXX | Substantially Equivalent | Qingdao Hainuo Biological Engineering Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 7, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.