GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD

FDA Device Registration & Listing · Foshan Guangdong, CN · Registration 3006621386

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
3006621386
FEI Number
3006621386
Entity Name
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD
City/State/Country
Foshan Guangdong, CN
Establishment Address
No.89 Taoyuan East Rd, Nanhai, Foshan Guangdong 528225, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Guangdong Baihe Medical Technology Co., Ltd. (Owner Number: 9097900)
Owner / Operator Contact Address
No.89, Taoyuan East Rd, Nanhai, Foshan, CN-GD 528225, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K102833
PMA Number
N/A

All Registered Proprietary Names

CMC Wound Dressing ABLE CENTRAL VENOUS CATHETER Disposable Hemodialysis Access Catheter Set

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2023-07-21
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2007-09-14
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2011-12-20

Official Correspondent

Rongzhang Cen

US Agent Details

Bryan Wong Business: PUREVISION AI, INC. (DBA PURE GLOBAL) Email: us-agent@pureglobal.com Phone: (888) 7681688

Related Public Records

Same Entity

Guangdong Baihe Medical Technology 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
K943349 Quinton, Inc. MAHURKAR DUAL LUMEN CATHETER 1995-03-22
K912158 Medical Device Inspection Co., Inc. CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY 1991-10-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024 ARROW INTERNATIONAL Inc. 2
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023 B Braun Medical Inc 2
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024 Becton Dickinson Infusion Therapy Systems Inc. 2
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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3043138901 DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD Dongguan Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006621386. Last updated year: 2026. Please use registration number 3006621386 when referencing this establishment in official correspondence.
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