Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011529314

FEI Number

3011529314

Entity Name

Nanjing J SUN Healthcare Co.,Ltd

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

No. 1, Sanjiangkou Industrial Park, Jing'an, Qixia District, Nanjing Jiangsu 210009, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Nanjing J SUN Healthcare Co.,Ltd (Owner Number: 10057025)

Owner / Operator Contact Address

No. 1, Sanjiangkou Industrial Park, Jing'an, Qixia District, Nanjing, CN-JS 210009, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dish, tissue culture Pad, Denture, Over The Counter bedding, disposable, medical HOOD, OXYGEN, INFANT Cover, Shoe, operating room X-Ray Detectable gauze sponge Catheters, suction, tracheobronchial Surgical scissors/trauma scissors Container, specimen, sterile ACCESSORY, SURGICAL APPAREL Mask Oxygen CPR mask Low concentration venturi Oxygen Mask Urine collection bags Ostomy-ostomy bag with adhesive butterfly closure/moleskin blister dressing medical adhesive tape and bandage face mask L&S CARE Cotton roll/cotton ball Disposable Skin Stapler Forceps Gauze sponge/non adherent pad Reuseable hot and cold Pack bottle cooler/hot and cold pack/cool gel pad/eye mask/facial mask/gel insole/gel slipers/Ice box/Ice pack Ssterile burn sheet MASK, SCAVENGING Tube, Aspirating,flexible, connecting SILICONE HYDROGEL FOR SCAR MANAGEMENT SYSTEM, SKIN CLOSURE Cotton Swabs,tipped applicato,,Absorbent Cotton,AlcoholPrep Pad Mask,Oxygen, low concentration, venturi CBP face mask Tweezer Protective apron Dental bibs Splinter remover Clamp vinyl Patient Examination Glove Plaster of Paris bandage Gown, examination non woven cohesive elastic bandage Cotton cohesive elastic bandage Medical Gauze bandage Alcohol prep pad Surgical knife Cannula Nasal, Oxygen Shield, protective, personnel L&S CARE Non-Rebreathing Oxygen mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2018-02-12
EHR	Pad, Denture, Over The Counter	Dental	Class 2	872.3540	2022-11-04
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2018-02-12
FOG	Hood, Oxygen, Infant	Anesthesiology	Class 1	868.5700	2020-03-23
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-03-23
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2018-03-07
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2018-02-12
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-03-07
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2018-02-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-23
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-02-12
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2018-03-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-03-07
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-15
EFN	Cotton, Roll	Dental	Class 1	872.6050	2018-03-07
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-11-04
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-03-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-03-07
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2018-03-07
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2018-08-31
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-23
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2018-02-12
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2022-11-02
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2022-11-02
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2020-06-07
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2018-02-12
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2018-03-15
KCX	Epilator, High Frequency, Tweezer-Type	General, Plastic Surgery	Class 1	878.5360	2018-03-07
IWO	Apron, Protective	Radiology	Class 1	892.6500	2018-03-07
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2023-05-19
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-03-07
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2018-03-07
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-03-23
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2018-02-12
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2020-05-18
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-03-07
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2018-02-12
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-04-14
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2018-03-07

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Nanjing J SUN Healthcare 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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0070-2019	COVIDIEN LLC	2	EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

Similar Registrations

Registration Number	Establishment Name	Location
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
3013894805	JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.	JIANGYAN Jiangsu, CN
1423662	Sterigenics US LLC	Gurnee, IL, US
3010194621	LABOTEK GROUP CORP	Bayamon, PR, US
1423537	Cardinal Health 200, LLC	Waukegan, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011529314. Last updated year: 2026. Please use registration number 3011529314 when referencing this establishment in official correspondence.