Nanjing J SUN Healthcare Co., Ltd.
Registered establishment in Nanjing, Jiangsu, China. 56 device types.
Nanjing J SUN Healthcare Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Clamp, Forceps and 54 other device types. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | Nanjing J SUN Healthcare Co.,Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011529314 |
| FEI number | 3011529314 |
| Establishment type | Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Nanjing |
|---|---|
| Province | Jiangsu |
| Address | No. 1, Sanjiangkou Industrial Park, Jing’an, Qixia District |
| Postal code | 210009 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Accessory, Surgical Apparel | 2020 | 439 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Airway, oropharyngeal,anesthesiology | 2018 | 84 |
| Apron, Protective | Class 1 | Protective apron, Dental bibs | 2018 | 46 |
| Bag, Drainage, With Adhesive, Ostomy | Class 1 | Urine collection bags, Ostomy-ostomy bag with adhesive | 2018 | 49 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Urine collection bags | 2018 | 52 |
| Bandage, Cast | Class 1 | vinyl Patient Examination Glove, Plaster of Paris bandage | 2018 | 81 |
| Bandage, Elastic | Class 1 | Medical Gauze bandage, non woven cohesive elastic bandage, Cotton cohesive elastic bandage | 2018 | 280 |
| Bedding, Disposable, Medical | Class 1 | bedding, disposable, medical | 2018 | 308 |
| Cannula, Nasal, Oxygen | Class 1 | Cannula Nasal, Oxygen | 2018 | 97 |
| Cap, Surgical | Class 1 | CAP, Surgical | 2020 | 178 |
| Catheter And Tip, Suction | Class 2 | Suction Catheter and tip, Yankauer Sauction Instrument with Thumb control hole | 2018 | 70 |
| Catheter, Infusion | Class 1 | Infusion catheter | 2018 | 8 |
| Catheters, Suction, Tracheobronchial | Class 1 | Catheters, suction, tracheobronchial | 2018 | 93 |
| Clamp | Class 1 | Clamp | 2018 | 24 |
| Container, Specimen, Sterile | Class 1 | Container, specimen, sterile | 2018 | 79 |
| Cotton, Roll | Class 1 | Cotton roll/cotton ball | 2018 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Cover, Shoe, operating room | 2020 | 176 |
| Depressor, Tongue, Non-Surgical | Class 1 | 2018 | 100 | |
| Dish, Tissue Culture | Class 1 | Dish, tissue culture | 2018 | 30 |
| Dress, Surgical | Class 1 | Dress, Surgical | 2020 | 71 |
| Dressing, Compression | Class 1 | Sterile compression dressing | 2018 | 87 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | dressing, wound, hydrogel without drug and/or biologic – Hydrogel w/wout drug wound dressing, or bilogic-hyfrogel wound dressing; Hydrophilic-foam wound dressing, Occlusive-Hydrocolloid wound dressing, Stickers with Tea Tree Oil and Calendula Oil, Hellados™ 450 Pimple Patches For Face, 4 Size Acne Patches, Hydrocolloid Zit Patches, Blemish Patches, Spot | 2018 | 118 |
| Epilator, High Frequency, Tweezer-Type | Class 1 | Tweezer | 2018 | 13 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | face mask L&S CARE | 2020 | 182 |
| Fiber, Medical, Absorbent | Class 1 | Cotton Swabs,tipped applicato,,Absorbent Cotton,AlcoholPrep Pad | 2020 | 172 |
| Forceps | Class 1 | Forceps | 2018 | 99 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze sponge/non adherent pad | 2018 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | X-Ray Detectable gauze sponge | 2018 | 67 |
| Gown, Examination | Class 1 | Gown, examination | 2020 | 109 |
| Hood, Oxygen, Infant | Class 1 | Hood, Oxygen, Infant | 2020 | 6 |
| Knife, Surgical | Class 1 | Surgical knife | 2018 | 8 |
| Mask, Oxygen | Class 1 | CPR mask, Low concentration venturi Oxygen Mask, Mask Oxygen | 2018 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Mask,Oxygen, low concentration, venturi | 2018 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Non-Rebreathing Oxygen mask | 2018 | 72 |
| Mask, Scavenging | Class 1 | Mask, Scavenging | 2020 | 158 |
| Non-Surgical Gown | Class 1 | non-surgical isolation gown | 2018 | 318 |
| Pack, Hot Or Cold, Reusable | Class 1 | bottle cooler/hot and cold pack/cool gel pad/eye mask/facial mask/gel insole/gel slipers/Ice box/Ice pack, Reuseable hot and cold Pack | 2018 | 178 |
| Pad, Alcohol, Device Disinfectant | Class U | Alcohol prep pad | 2020 | 49 |
| Pad, Denture, Over The Counter | Class 2 | Pad, Denture, Over The Counter | 2022 | 2 |
| Pad, Eye | Class 1 | Pad, Eye | 2022 | 100 |
| Scalpel, One-Piece | Class 1 | Splinter remover | 2023 | 14 |
| Scissors, General, Surgical | Class 1 | Surgical scissors/trauma scissors | 2018 | 83 |
| Sheet, Burn | Class 1 | Ssterile burn sheet | 2018 | 20 |
| Shield, Protective, Personnel | Class 1 | Shield, protective, personnel L&S CARE | 2020 | 78 |
| Shoe And Shoe Cover, Conductive | Class 1 | Shoe cover | 2018 | 32 |
| Silicone Hydrogel For Scar Management | Class 1 | Silicone Hydrogel FOR Scar Management | 2022 | 22 |
| Sling, Arm | Class 1 | Arm Sling / triangular bandage | 2018 | 126 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | non-inflatable, non-sterile, external, splint, extremity, | 2018 | 62 |
| Stapler, Surgical | Class 2 | Disposable Skin Stapler | 2019 | 16 |
| Suit, Surgical | Class 1 | Suit, Surgical | 2020 | 74 |
| System, Skin Closure | Class 1 | System, Skin Closure | 2022 | 10 |
| Tape And Bandage, Adhesive | Class 1 | medical adhesive tape and bandage, butterfly closure/moleskin blister dressing | 2018 | 353 |
| Thermometer, Clinical Color Change | Class 1 | Clinical thermometer | 2018 | 15 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet | 2018 | 124 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Tube, Aspirating,flexible, connecting | 2018 | 51 |
| Valve, Non-Rebreathing | Class 2 | CBP face mask | 2018 | 19 |
Clearances
No clearance names Nanjing J SUN Healthcare Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K171961 | 2017-11-17 | CBP | Traditional | Xiamen Compower Medical Tech. Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Employees | 100 |
| Factory area | 3000 square meters |
| Main products | Acne patches, Hydrocolloid dressings, Blister patches, Ostomy bags, Nose strips |
| Certifications | GMP, FDA, ISO13485, CE |
| Export markets | 50+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.