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
Tips And Pads, Cane, Crutch And Walker INP
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use PYO
Pad, Eye HMP
Nursing Pad, Hydrogel NTC
Mask, Oxygen, Low Concentration, Venturi BYF
First Aid Kit With Drug LRR
Tourniquet, Nonpneumatic GAX
Mask, Surgical FXX
Floss, Dental JES
Mask, Scavenging KHA
Tape And Bandage, Adhesive KGX
Silicone Hydrogel For Scar Management PFP
Patient Examination Glove FMC
Burn Kit Without Drug OJJ
Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
Sprays, Synthetic, Smear IFI
Scissors, Wire Cutting, Ent, Non-Sterile NNU
Pad, Menstrual, Intralabial NUR
Shield, Protective, Personnel KPY
Personal Protection Kit PXC
Catheter, Nasal, Oxygen BZB
Cover, Shoe, Operating-Room FXP
Adaptor, Ureteral Catheter EYI
Pad, Menstrual, Unscented HHD
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) NTX
Pack, Hot Or Cold, Disposable IMD
Kit, Test, Pregnancy, Hcg, Over The Counter LCX
Applicator, Absorbent Tipped, Non-Sterile KXF
Scissors, Wire Cutting, Ent, Sterile JYA
Non-Surgical Gown OEA
First Aid Kit Without Drug OHO
Holder, Ureteral Catheter EYJ
Strap, Head, Gas Mask BTK
Pad, Alcohol, Device Disinfectant LKB
Nursing Pad, Cohesive Gel NXH
Mask, Oxygen, Non-Rebreathing KGB
Mask, Gas, Anesthetic BSJ
Dressing, Wound, Hydrophilic NAC
Bandage, Elastic FQM
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
Mask, Oxygen BYG
Catheter, Nasopharyngeal ENW
Cap, Surgical FYF
Depressor, Tongue, Non-Surgical FMA
Mouthguard, Over-The-Counter OBR
Maternity Kit PVT
Sheet, Burn FPY
Pad, Menstrual, Reusable NUQ
Gauze / Sponge,Nonresorbable For External Use NAB
Kit, First Aid, Talking OVR
Disinfectant, Medical Devices LRJ
Dermatome GFD
Stylet, Ureteral EYA
Catheter, Drainage, Intraoral/Extraoral OAJ
Pad, Kelly FNW
Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile NRC
Radiographic Protective Glove IWP
Nasal Spray, Ent Delivery KCO
Elastomer, Silicone, For Scar Management MDA
Cotton, Roll EFN
Catheters, Suction, Tracheobronchial BSY

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)