SHENZHEN BI-RICH MEDICAL DEVICES CO., LTD

FDA Device Registration & Listing · Shenzhen City Guangdong, CN · Registration 3011716786

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
3011716786
FEI Number
3011716786
Entity Name
SHENZHEN BI-RICH MEDICAL DEVICES CO., LTD
City/State/Country
Shenzhen City Guangdong, CN
Establishment Address
No. 10, Xinqiao GangZai Road, Xinqiao Street, BaoAn District, Shenzhen City Guangdong 518125, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shenzhen Bi-Rich Medical Devices Co., Ltd. (Owner Number: 10049196)
Owner / Operator Contact Address
No.10, Xinqiao GanZai Road, Xingiao Street, Bao'An District, Shenzhen, CN-GD 518125, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Nebulizer Compressor Nebulizer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2021-01-06
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 2025-11-17
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2016-08-19
OJR Vacuum Powered Body Fluid Collection Kit General, Plastic Surgery Class 2 878.4780 2021-04-23
BTA Pump, Portable, Aspiration (Manual Or Powered) General, Plastic Surgery Class 2 878.4780 2021-05-19
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2021-01-06
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2015-04-27

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Shenzhen Bi-Rich Medical Devices Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3036830503 Bi-Rich Medical Devices (Cambodia) Co. Ltd BAVET Svay Rieng, KH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07
K812750 Instrumentation Laboratory CO IL 703, STAT SEPARATOR 1982-01-26
K900686 Medical Industries America, Inc. MAXI COMPRESSORS 1990-04-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2007 Haemonetics Corporation 2
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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3010594263 JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD. Shuyang Jiangsu, CN
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3003902679 ENTER MEDICAL CORPORATION Chiayi County, TW
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011716786. Last updated year: 2026. Please use registration number 3011716786 when referencing this establishment in official correspondence.
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