Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013909820

FEI Number

3013909820

Entity Name

NINGBO LUKE MEDICAL DEVICES CO., LTD.

City/State/Country

Yuyao Zhejiang, CN

Establishment Address

Gujiayan, Yangming Road, 315400 Yuyao City, Zhejiang Province, China, Yuyao Zhejiang 315400, CN

Establishment Type(s)

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

Owner / Operator

Ningbo Luke Medical Devices Co., Ltd. (Owner Number: 10056138)

Owner / Operator Contact Address

Gujiayan, Yangming Road, 315400 Yuyao City, Zhejiang Province, China, Yuyao, CN-ZJ 315400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kegel Ball Headgear Latex free breathing bag Nasopharyngeal Airway Drainage Tubes Drainage Bag Isolation Gown Wound Drainage Systems PVC wound drainage system, PVC reservoirs Nebulize Mask CPAP Tube Disposable Breathing Circuits Face Mask Face Shield stomach tube (Gastric Calibration Tube ) Silicone Loops Oxygen Masks CPAP Mask Aerosol Non-breathing Oxygen Mask Venturi Mask Nasal Oxygen Cannulas Disposable Face Mask Anesthesia Mask Laryngeal Mask Airways Oropharyngeal Airway

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	Class 2	884.5960	2020-02-26
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2020-03-01
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2023-09-21
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2020-03-01
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-02-27
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-03
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2017-11-08
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2020-03-01
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-02-27
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-01
PRM	Enteral Administration Kit (Adult & Pediatric)	Gastroenterology, Urology	Class 2	876.5980	2019-09-26
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-03-01
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2017-11-08
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2020-02-27
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2020-03-01
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2017-11-08
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	2020-03-28
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2020-03-01
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2017-11-08

Official Correspondent

Yehua Zhang

US Agent Details

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

Related Public Records

Same Entity

Ningbo Luke Medical Devices 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

Registration Number	Establishment Name	Location
3016147813	TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO., LTD.	Tianjin, CN
3012074930	HEARTLAND TECHNOLOGY DONGGUAN CO.,LTD.	Dongguan Guangdong, CN
3039346136	YANKANG MEDICAL INSTRUMENT CO., LTD.	Taipei, TW
3042254879	SHENZHEN HONGZHUN ZHIZAO TECHNOLOGY CO., LTD	Shenzhen Guangdong, CN
3023395601	ALL ABOUT INSPIRED COMPANY LIMITED	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013909820. Last updated year: 2026. Please use registration number 3013909820 when referencing this establishment in official correspondence.