Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017450368

FEI Number

3017450368

Entity Name

ZHEJIANG SAINING BIOTECHNOLOGY CO.,LTD

City/State/Country

Taizhou Zhejiang, CN

Establishment Address

1st floor,building3,LANWAN scientific innovation center,No.28,YouyiRoad,Baita Town,Xianju County, Taizhou Zhejiang 317300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZHEJIANG SAINING BIOTECHNOLOGY CO.,LTD (Owner Number: 10075772)

Owner / Operator Contact Address

1st floor,building3,LANWAN scientific innovation center,No.28,YouyiRoad,Baita Town,Xianju County, Taizhou, CN-ZJ 317300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CONDUCTIVE TIP PCR SINGLE TUBE PCR 8 STRIP TUBE CAPS FOR PCR 8 STRIP TUBE PCR 96 WELL PLATE CHAMBER SLIDE ELISA PLATE FLASK TISSUE CULTURE DISH CELL CULTURE PLATE TRANSWELL INSERT culture tube BACTERIA CULTURE DISH FILTER TIP NON FILTERED TIP SYRINGE-DRIVEN FILTER CRYOGENIC VIAL SAMPLE STORAGE TUBE DEEP WELL PLATE TIP COMB SEROLOGICAL PIPETTE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-01-11
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2022-01-11
GHO	Hemocytometer	Hematology	Class 1	864.6160	2022-12-02
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2022-12-02
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2022-01-11
KJG	Tube, Tissue Culture	Pathology	Class 1	864.3010	2022-01-11
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2023-11-07
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2022-01-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-11-07
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2022-01-11
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2022-01-11

Official Correspondent

Sandra Zhang

US Agent Details

Rebecca Toman Email: cs@ltlqa.com Phone: (281) 6008227

Related Public Records

Same Entity

ZHEJIANG SAINING BIOTECHNOLOGY 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-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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017450368. Last updated year: 2026. Please use registration number 3017450368 when referencing this establishment in official correspondence.