Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008808560

FEI Number

3004601847

Entity Name

Hynaut Health Technology Co., LTD.

City/State/Country

Qingdao Shandong, CN

Establishment Address

Jiangshan Industrial Area, Laixi, Qingdao Shandong 266603, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hynaut Health Technology Co., LTD. (Owner Number: 10040387)

Owner / Operator Contact Address

Jiangshan Industrial Area, Laixi, Qingdao, CN-SD 266603, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Scissors First aid kit holder strap Alcohol Wipes, Alcohol prep pad nursing pad mask mask Wound Dressing,I.V. Adhesive Dressing Elastic Bandage,Gauze Bandage C004; C005; C006; C012; C017; C022; C023; C024; KN95 Protective Mask mask Nasopharyngeal Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2024-08-26
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	General Hospital	Class 1	880.5240	2024-08-26
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2024-08-26
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2024-08-26
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2024-08-26
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2024-08-26
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2024-08-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-05-07
JES	Floss, Dental	Dental	Class 1	872.6390	2019-11-06
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-04-14
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-04-09
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2024-08-26
FMC	Patient Examination Glove	General Hospital	Class 1	880.6250	2020-09-05
OJJ	Burn Kit Without Drug	General, Plastic Surgery	Class 1	878.4022	2024-08-26
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-08-26
IFI	Sprays, Synthetic, Smear	Pathology	Class 1	864.4010	2024-08-26
NNU	Scissors, Wire Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2024-08-26
NUR	Pad, Menstrual, Intralabial	Obstetrics/Gynecology	Class 1	884.5435	2024-08-26
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2021-07-20
PXC	Personal Protection Kit	General Hospital	Class 1	880.6250	2020-11-11
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2024-08-26
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-08-11
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2024-08-26
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2024-08-26
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	General Hospital	Class 1	880.5630	2024-08-26
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2012-04-09
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2021-07-20
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2017-07-31
JYA	Scissors, Wire Cutting, Ent, Sterile	Ear, Nose, Throat	Class 1	874.3540	2024-08-26
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-06
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2019-11-07
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2024-08-26
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2024-08-26
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2018-11-02
NXH	Nursing Pad, Cohesive Gel	General Hospital	Class 1	880.5630	2024-08-26
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2024-08-26
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2024-08-26
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2017-07-31
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2012-04-09
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-11
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2024-08-26
ENW	Catheter, Nasopharyngeal	Ear, Nose, Throat	Class 1	874.4175	2024-08-26
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

Xinyue Ma Email: michelle.hynaut@gmail.com Phone: (949) 4136742

Related Public Records

Same Entity

Hynaut Health Technology Co., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008808560. Last updated year: 2026. Please use registration number 3008808560 when referencing this establishment in official correspondence.