Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022568093

FEI Number

3022568093

Entity Name

NINGBO HANYUE MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

CIXI CITY Zhejiang, CN

Establishment Address

NO.58 YUGONG ROAD, ERTANG INDUSTRIAL ZONE, ZONGHAN STREET, CIXI CITY Zhejiang 315300, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ningbo hanyue medical technology CO.,LTD (Owner Number: 10084707)

Owner / Operator Contact Address

NO.58 YUGONG ROAD, ERTANG INDUSTRIAL ZONE, ZONGHAN STREET, CIXI CITY, CN-ZJ 315300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Menstrual Cup Nasopharyngeal Airway Nasal Oxygen Cannulas Choking Rescue Device Combat application Tourniquets Nebulize Mask Kegel Ball CPR Mask; Non-Breathing Oxygen Mask Heat Moisture Exchange Filter Choking Rescue Device, Choke Reliever First Aid Kit Without Drug Hunidifier Chamber Foam Dressing, Hydrocolloid Dressing, Hydrocolloid Foam Dressina, Silicone Dressing, NPWT Dressing, Nonwoven wound dressind, Super Absorbency Dressing, Transparent Dressing, CovaWound (Confidential), MedNac (Confidential) Waterproof Cast Protector Breathing Exerciser Wound Closure Device Pump, Nebulizer, Electrically Powered ECG Electrodes CPAP mask; Continuous Positive Airway Pressure Mask; Non-lnvasive Ventilation Mask First Aid Kit With Drug

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2024-06-13
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2022-03-24
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2022-03-24
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2024-06-13
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-03-24
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2022-03-24
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	Class 2	884.5960	2024-06-13
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2022-03-24
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2022-03-24
MZT	Device, Heimlich Maneuver Assist	Anesthesiology	Class 2	868.5115	2025-05-15
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2024-06-13
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2022-03-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-09-09
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2023-06-01
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2024-09-13
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	2025-09-09
JPW	Pump, Nebulizer, Electrically Powered	Ear, Nose, Throat	Class 1	874.5220	2025-02-27
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2025-07-18
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2022-03-24
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2024-06-13

Official Correspondent

litao Chen

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Ningbo hanyue medical 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022568093. Last updated year: 2026. Please use registration number 3022568093 when referencing this establishment in official correspondence.