Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008157119

FEI Number

3008157119

Entity Name

Saint-Gobain Life Sciences (Hangzhou) Co., Ltd

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

1268, Zhixing Road, Xiaoshan Qiaonan Industrial Zone, Hangzhou Zhejiang 311231, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. (Owner Number: 10046781)

Owner / Operator Contact Address

1268, Zhixing Road, Xiaoshan Qiaonan Industrial Zone, Hangzhou, CN-ZJ 311231, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORIGIO Gas Line Filter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2014-05-12

Official Correspondent

Lillian Zhang

US Agent Details

Dannelle Lao Business: Saint-Gobain Email: Dannelle.Lao@saint-gobain.com Phone: (727) 7969026

Related Public Records

Same Entity

Saint-Gobain Life Sciences (Hangzhou) 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-0029-2020	CooperSurgical, Inc.	2	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008157119. Last updated year: 2026. Please use registration number 3008157119 when referencing this establishment in official correspondence.