Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007154442

FEI Number

3007154442

Entity Name

Mandarin Enterprises, LLC

City/State/Country

Atlanta, GA, US

Establishment Address

2625 PIEDMONT RD NE STE 56-129, Atlanta, GA 30324, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Mandarin Enterprises, LLC (Owner Number: 10024035)

Owner / Operator Contact Address

3482 Oakcliff Rd, Suite F, Doraville, GA 30340, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Clinical Guard Mandarin Enterprises LLC Mandarin Enterprises LLC Clinical Guard Clinical Guard Mandarin Enterprises LLC Clinical Guard Mandarin Enterprises LLC Mandarin Enterprises LLC Mandarin Enterprises LLC Mandarin Enterprises LLC Clinical Guard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-04-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-17
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2020-04-17
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2020-04-17
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2016-02-16
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2016-02-16

Official Correspondent

Jason Gao

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mandarin Enterprises, LLC

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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007154442. Last updated year: 2026. Please use registration number 3007154442 when referencing this establishment in official correspondence.