SHANGHAI BARON TECHNOLOGIES CO LTD

FDA Device Registration & Listing · Shanghai, CN · Registration 3010397428

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010397428
FEI Number
3010397428
Entity Name
SHANGHAI BARON TECHNOLOGIES CO LTD
City/State/Country
Shanghai, CN
Establishment Address
No. 196, Luji Road, Pudong New District, Shanghai 201322, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SHANGHAI BARON TECHNOLOGIES CO LTD (Owner Number: 10045021)
Owner / Operator Contact Address
No. 196, Luji Road, Pudong New District, Shanghai, CN-SH 201322, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CUSHION AIRFIT N20 MED SPARE CUSHION AIRFIT N20 LGE SPARE CUSHION AIRFIT N20 SML SPARE Swift Cushion Anesthetic Gas Mask

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-01-24
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-01-24
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2013-09-15

Official Correspondent

Susan Zhao

US Agent Details

Dylan Alu Email: dylan.alu@parker.com Phone: (215) 6608132

Related Public Records

Same Entity

SHANGHAI BARON TECHNOLOGIES CO LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K792722 Novametrix Medical Systems, Inc. NOVAMETRIX CPAP NASAL CANNULA 1980-01-24
K082979 Resmed, Ltd. S8 ADVANCE 2009-01-02
K203126 Resmed Pty , Ltd. S10 Kirra 2020-12-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2020 TELEFLEX-MORRISVILLE 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010397428. Last updated year: 2026. Please use registration number 3010397428 when referencing this establishment in official correspondence.
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