Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006769302

FEI Number

3006769302

Entity Name

SUNTECH MEDICAL DEVICES (SHENZHEN) CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

105 Huanguan South Road,Suite15, 2-3/F, Dahe Cummunity, GuanHu Subdistrict, LongHua District,, Shenzhen Guangdong 518110, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Suntech Medical Devices (Shenzhen) Co., Ltd, (Owner Number: 10034244)

Owner / Operator Contact Address

105 Huanguan South Road,Suite15,2-3/F, Dahe Community, Guanhu Sub-district, LongHua District, Shenzhen, CN-GD 518110, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DISPOSABLE CUFF CT40 Vital Signs Tango M2 ALL PURPOSE CUFF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2010-11-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-09-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-03-31
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2010-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Tonia Bryant Business: SunTech Medical, Inc Email: tbryant@suntechmed.com Phone: (919) 6542314

Related Public Records

Same Entity

Suntech Medical Devices (Shenzhen) 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
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17
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

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.

Similar Registrations

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3031192529	Zhejiang LuDe Technology Development Co., Ltd.	Wenzhou Zhejiang, CN
3002865611	BALLERSTEDT GMBH	Reinbek Schleswig-Holstein, DE
3009154535	WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD.	Wenzhou City Zhejiang, CN
1058002	Technicuff Corp.	LEESBURG, FL, US
3001570235	GE Medical Systems Information Technologies, Inc.	Waukesha, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006769302. Last updated year: 2026. Please use registration number 3006769302 when referencing this establishment in official correspondence.