Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007361214

FEI Number

3007361214

Entity Name

SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

1/F, Zhongtianxin Building B, Longgang District,Shenzhen,Guangdong, Shenzhen Guangdong 518172, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sunny Medical Device (Shenzhen) Co., Ltd. (Owner Number: 10043316)

Owner / Operator Contact Address

1/F, Zhongtianxin Building B, Longgang District, Shenzhen, Guangdong, Shenzhen, CN-GD 518172, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153685

PMA Number

N/A

All Registered Proprietary Names

SunmedTM Inflation Device SunmedTM guidewire torque device SunmedTM Inflation Device SunmedTM Protective face shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2015-08-18
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2020-09-09
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2019-01-21
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-08-18
DRC	Trocar	Cardiovascular	Class 2	870.1390	2019-01-03
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2020-04-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-11-03
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2016-11-03

Official Correspondent

James Zhang

US Agent Details

JAMES QI ZHANG Email: jamesqizhang@gmail.com Phone: (949) 3656488

Related Public Records

Same Entity

Sunny Medical Device (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
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Similar Registrations

Registration Number	Establishment Name	Location
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
3010149039	FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD	Changzhou Jiangsu, CN
1526863	ICU Medical, Inc.	DUBLIN, OH, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007361214. Last updated year: 2026. Please use registration number 3007361214 when referencing this establishment in official correspondence.