Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011676045

FEI Number

3011676045

Entity Name

HAIMEN SHENGBANG LABORATORY EQUIPMENT CO., LTD

City/State/Country

Haimen Jiangsu, CN

Establishment Address

No.126,Team 9, Zhangbei Village, Haimen Jiangsu 226113, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HAIMEN SHENGBANG LABORATORY EQUIPMENT CO., LTD (Owner Number: 10049185)

Owner / Operator Contact Address

No.126,Team 9, Zhangbei Village, Haimen, CN-JS 226113, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Microscope Slides /Cover glasses Slides Salvia Collecting Kit flocking swabs sampling collector Cryogenic Tubes (Brand: medrock26), Blood collection tube Holder centrifuge tube, cryo tube, Cell Spreader , Loops, PCR Tube, PCR plate , Test Tube face mask petri dish, Culture Plate/Tissue Culture Plate, Deep well plate pipette tips centrifuge tube rack, Test Tube Rack, Staining Jar and Racks Swabs/Swabs with medium Biopsy Cassette/Embedding Cassette face mask Specimen collection kit oral swabs,nasal swabs,flocking swabs Sterile Swabs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2015-04-26
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2024-02-27
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2021-02-23
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2015-04-26
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-24
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2015-04-26
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2015-04-26
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-04-26
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2015-04-26
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2015-04-26
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	2020-05-08
NNT	Punch, Gelfoam, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2024-02-18
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-06-15

Official Correspondent

Lei Fan

US Agent Details

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

Related Public Records

Same Entity

HAIMEN SHENGBANG LABORATORY EQUIPMENT 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
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011676045. Last updated year: 2026. Please use registration number 3011676045 when referencing this establishment in official correspondence.