Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010583519

FEI Number

3010583519

Entity Name

NINGBO MFLAB MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

Economic Development Zone, Yinzhou, District, Ningbo Zhejiang 315145, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Ningbo MFLAB Medical Instruments Co., Ltd. (Owner Number: 10045286)

Owner / Operator Contact Address

Economic Development Zone, Yinzhou, District, Ningbo, CN-ZJ 315145, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Distribution Unlimited Yankauer Handles with Suction Tubing Yankauer,Suction Yankauer, Connecting Tubings with Yankauer Handle non-rebreathing mask Venturi mask, Adjustable Venturi Mask Suction Catheter Distribution Unlimited ETCO2 Nasal Cannula, Distribution Unlimited Nasal Oxygen Cannula Nasal Oxygen Cannula Oxygen mask Distribution Unlimited Sterile Specimen Containers with Temperature Strip Urine container, sterile, SPECIMEN BAG Distribution Unlimited Oxygen Connecting Tubing Suction Tubing, Suction Connecting Tubing, Connecting Tubing Spacers for Aerosol

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2015-04-08
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2020-06-10
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2015-08-17
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2017-05-31
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2013-11-04
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2014-03-31
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2013-11-04
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2015-04-08
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2024-02-20

Official Correspondent

Lichun Wu

US Agent Details

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

Related Public Records

Same Entity

Ningbo MFLAB Medical Instruments Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

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3027150141	SWIFTSURE INNOVATIONS INC.	Pasadena Newfoundland and Labrador, CA
3015337348	Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010583519. Last updated year: 2026. Please use registration number 3010583519 when referencing this establishment in official correspondence.