Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010008150

FEI Number

3010008150

Entity Name

UNIVAC PRECISION PLASTICS (SUZHOU) CO.,LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Blk 2, 3E Industrial Park, No.18, Chunyao Rd, XiangCheng District, Suzhou City, Jiangsu Province, China 215143, Suzhou Jiangsu 215143, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Univac Precision Plastics (Suzhou) Co.,Ltd (Owner Number: 10081153)

Owner / Operator Contact Address

Blk 2, 3E Industrial Park, No.18, Chunyao Rd, XiangCheng District, Suzhou City, Jiangsu Province, China 215143, Suzhou, CN-JS 215143, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OXYSAFE2 CANNULA VALVE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2021-03-21

Official Correspondent

Mary Chen

US Agent Details

Rajat Kumar Email: rajat.kumar@univac.com.sg Phone: (510) 3599264

Related Public Records

Same Entity

Univac Precision Plastics (Suzhou) 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 3010008150. Last updated year: 2026. Please use registration number 3010008150 when referencing this establishment in official correspondence.