Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017434950

FEI Number

3017434950

Entity Name

JIANSHI Biotechnology (Zhejiang) Co., Ltd.

City/State/Country

Yuyao Zhejiang, CN

Establishment Address

Building 11, Zhongyiqidi industrial Zone,Qianwan New District, Ningbo, Zhejiang, China, Yuyao Zhejiang 315400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JIANSHI Biotechnology (Zhejiang) Co., Ltd. (Owner Number: 10072160)

Owner / Operator Contact Address

Building 11, Zhongyiqidi industrial Zone,Qianwan New District, Ningbo, Zhejiang, 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

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-05-05
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-05-05
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	2020-11-07
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-04-27

Official Correspondent

Luz Zhang

US Agent Details

Luigi Basilio Email: lbasilio@zymoresearch.com Phone: (949) 6791190

Related Public Records

Same Entity

JIANSHI Biotechnology (Zhejiang) Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017434950. Last updated year: 2026. Please use registration number 3017434950 when referencing this establishment in official correspondence.