Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007858728

FEI Number

3007858728

Entity Name

Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Floor 14, Block D,Dianlian Technology Building, the Crossing between South Circle Road and South Fuli Road, Guangming District,, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd (Owner Number: 10078546)

Owner / Operator Contact Address

Floor 14, Block D,Dianlian Technology Building, the Crossing between South Circle Road and South Fuli Road, Guangming District,, Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pulse oximeter 44-50K C6 PO250D PO30 A3 C9 C1 C7 C8 88-50K 11-50K C4 A2 UP-200 A5 11-50D 71-50K 52-50K 74-50K 90-50D C3 PX-200R PO 13 73-50K C5 67-50F 73-50D 74-50D 64-50DRR C2 C4 C8 C1 500DL DT50 PX-560BTCO One Trip A2 C9 85301 C6 75045 C3 AC-D1 C5 FL400 A3 A5 C7 POX-ROS C2 FL350 CCI-50DL 75059

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2020-10-27
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2025-12-23

Official Correspondent

Liu Bo

US Agent Details

Anny zhao Business: Hlongmed International Ltd. Email: usagent@hlongmed.com Phone: (503) 3344880

Related Public Records

Same Entity

Shenzhen Hexin ZONDAN Medical Equipment 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 3007858728. Last updated year: 2026. Please use registration number 3007858728 when referencing this establishment in official correspondence.