Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017178434

FEI Number

3017178434

Entity Name

SUZHOU CELLPRO BIOTECHNOLOGY CO.,LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Building 1, CECEP (Suzhou) , Environmental Technology Industrial Park, No. 18, Dongchang Road, Suzhou Industrial Park, Suzhou Jiangsu 215217, CN

Establishment Type(s)

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

Owner / Operator

Suzhou Cellpro Biotechnology Co.,Ltd. (Owner Number: 10081295)

Owner / Operator Contact Address

Building 1, CECEP (Suzhou), Environmental Technology Industrial Park, No. 18, Dongchang Road, Suzhou Industrial Park, Suzhou, CN-JS 215217, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elisa Plate, Erlenmeyer Flasks Storage Bottles, Media bottles Conical Centrifuge Tube, Deep Well Plate, Screw Cap Micro Tube PCR Tube, PCR plate, PCR sealing Film,Micro Centrifuge Tube, Tip Comb pipette Pipette Tips Urine Container, Specimen Container, Reagent Reservoir, Serological Pipette, Erlenmeyer Flask, Cryovial Tubes, Media Bottle, Cell Roller Bottle, Thermoplastic Elastomer Tubing, Platinum-Cured Silicone Tubing Storage Boxes/Rack, Microscope Slide, Reagent Bottle, Vacuum Filtration Unit, Syringe Filters, Inoculating Needles, Cell Culture Plate, Cell Culture Flask, Cell Culture Dish, Multi-layer Cell Culture Chambers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2021-03-31
KJC	Bottle, Roller, Tissue Culture	Hematology	Class 1	864.2240	2024-12-05
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2021-03-31
GJW	Pipette, Pasteur	Hematology	Class 1	864.6160	2021-03-31
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2022-12-19
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2021-03-31

Official Correspondent

Mingjun Li

US Agent Details

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

Related Public Records

Same Entity

Suzhou Cellpro 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.

Similar Registrations

Registration Number	Establishment Name	Location
3010594946	Holocraft Corporation dba Flexcraft Company	Neptune City, NJ, US
1055789	WATAUGA OPPORTUNITIES, INC.	BOONE, NC, US
3001124136	INNOPEX LIMITED	Toronto Ontario, CA
3013530901	HANGZHOU ROLLMED CO.,LTD.	Hangzhou Zhejiang, CN
3019387954	DIATRUST MEDICAL CO., LTD.	Nanjing City Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017178434. Last updated year: 2026. Please use registration number 3017178434 when referencing this establishment in official correspondence.