Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016919945

FEI Number

3016919945

Entity Name

Shanghai Gene Era Bio-Science Co., Ltd.

City/State/Country

Fengxian Shanghai, CN

Establishment Address

No.211 East Huancheng Road, Fengxian Shanghai 201400, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Shanghai Gene Era Bio-Science Co., Ltd. (Owner Number: 10066778)

Owner / Operator Contact Address

No.211 East Huancheng Road, Fengxian, CN-SH 201400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gene Gene Gene Gene Gene Gene

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-02
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-02-21
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-02
JRA	Microtitrator, For Clinical Use	Clinical Chemistry	Class 1	862.2680	2023-01-17
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2022-02-21
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-02

Official Correspondent

Ziyan Zhang

US Agent Details

ZHENG XU Email: cathygeng2007@gmail.com Phone: (248) 5508758

Related Public Records

Same Entity

Shanghai Gene Era Bio-Science 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 3016919945. Last updated year: 2026. Please use registration number 3016919945 when referencing this establishment in official correspondence.