FDA Registration
Active
🇨🇳 China
Hynaut Health Technology Co., LTD.
Reg #: 3008808560
·
FEI: 3004601847
·
Expires 2026
Products
61
Proprietary Names
48
Establishment Types
3
Classifications
61
Registration Details
- Registration Name
- Hynaut Health Technology Co., LTD.
- Registration Number
- 3008808560
- FEI Number
- 3004601847
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Jiangshan Industrial Area, Laixi
- City
- Qingdao Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K210218
Owner / Operator
- Firm Name
- Hynaut Health Technology Co., LTD.
- Operator Number
- 10040387
- Address
- Jiangshan Industrial Area, Laixi
- City
- Qingdao
- State
- Shandong
- Postal Code
- 266603
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2024-08-26 |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | Class 1 | General Hospital | No | 2024-08-26 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2024-08-26 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2024-08-26 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2024-08-26 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-05-07 |
| Floss, Dental | JES | Class 1 | Dental | No | 2019-11-06 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-04-14 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-04-09 |
| Silicone Hydrogel For Scar Management | PFP | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Patient Examination Glove | FMC | Class 1 | General Hospital | No | 2020-09-05 |
| Burn Kit Without Drug | OJJ | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Sprays, Synthetic, Smear | IFI | Class 1 | Pathology | No | 2024-08-26 |
| Scissors, Wire Cutting, Ent, Non-Sterile | NNU | Class 1 | Ear, Nose, Throat | No | 2024-08-26 |
| Pad, Menstrual, Intralabial | NUR | Class 1 | Obstetrics/Gynecology | No | 2024-08-26 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2021-07-20 |
| Personal Protection Kit | PXC | Class 1 | General Hospital | No | 2020-11-11 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2024-08-26 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-08-11 |
| Adaptor, Ureteral Catheter | EYI | Class 1 | Gastroenterology, Urology | No | 2024-08-26 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2024-08-26 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | Class 1 | General Hospital | No | 2024-08-26 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2012-04-09 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2021-07-20 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2017-07-31 |
| Scissors, Wire Cutting, Ent, Sterile | JYA | Class 1 | Ear, Nose, Throat | No | 2024-08-26 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-05-06 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2019-11-07 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2024-08-26 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2024-08-26 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2018-11-02 |
| Nursing Pad, Cohesive Gel | NXH | Class 1 | General Hospital | No | 2024-08-26 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2024-08-26 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2024-08-26 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2017-07-31 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2012-04-09 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-11 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2024-08-26 |
| Catheter, Nasopharyngeal | ENW | Class 1 | Ear, Nose, Throat | No | 2024-08-26 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-08-11 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2024-08-26 |
| Mouthguard, Over-The-Counter | OBR | Class U | Unknown | No | 2018-11-02 |
| Maternity Kit | PVT | Class 1 | Obstetrics/Gynecology | No | 2024-08-26 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2024-08-26 |
| Pad, Menstrual, Reusable | NUQ | Class 1 | Obstetrics/Gynecology | No | 2024-08-26 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2018-11-02 |
| Kit, First Aid, Talking | OVR | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2019-11-06 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Stylet, Ureteral | EYA | Class 1 | Gastroenterology, Urology | No | 2024-08-26 |
| Catheter, Drainage, Intraoral/Extraoral | OAJ | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Pad, Kelly | FNW | Class 2 | General, Plastic Surgery | No | 2024-08-26 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | Class 1 | Obstetrics/Gynecology | No | 2024-08-26 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2020-11-11 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2024-08-26 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2024-08-26 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2024-08-26 |
Proprietary Names
eye pad
Bandage
tips and pads
nursing pad, hydrogel
mask
first aid kit
tourniquet
SURGICAL MASK
Floss pick
disposable mask
Medical Tape, Adhesive Bandage, Wound Plaster
Silicone Hydrogel
Burn kit
dressing
sprays, synthetic, smear
Scissors
pad
Face Shield
Disposable Vinyl Gloves , Disposable Nitrile Gloves
nasal catheter
adaptor
menstrual Pad
nursing pad
Warm Patch, Cold Pack, Cool Patch, Fever Relief Patch, Cool gel, Freeze gel
HCG Test Strip
Cotton Swab
First aid kit
holder
strap
Alcohol Wipes, Alcohol prep pad
Wound Dressing,I.V. Adhesive Dressing
Elastic Bandage,Gauze Bandage
C004; C005; C006; C012; C017; C022; C023; C024; KN95 Protective Mask
Nasopharyngeal Catheter
nasal irrigator
Face Mask
maternity kit
sheet
menstrual pad
Gauze Pad, Underpad, Cotton balls
Iodine swab
Dermatome
ureteral stylet
Catheter
nasal spray
elastomer
cotton, roll
Suctiion catheters
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)