Data / Medical devices / China / Nanjing J SUN Healthcare Co.,Ltd
Nanjing J SUN Healthcare Co.,Ltd: FDA-registered device maker in Nanjing Jiangsu, China, 1 510(k) clearance
Nanjing J SUN Healthcare Co.,Ltd is registered with the FDA (registration 3011529314) in Nanjing Jiangsu, China. It lists 56 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 17, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011529314
- Address
- No. 1, Sanjiangkou Industrial Park, Jing'an, Qixia District, Nanjing Jiangsu, China, 210009
- Owner or operator
- Nanjing J SUN Healthcare Co.,Ltd (10057025)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- February 12, 2018
- Registered through
- 2026
- Brand names listed
- ACCESSORY, SURGICAL APPAREL, Airway, oropharyngeal,anesthesiology, Alcohol prep pad, Arm Sling / triangular bandage, CAP, SURGICAL, CBP face mask, CPR mask, Cannula Nasal, Oxygen and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US | accessdata.fda.gov |
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Exporter to the US | accessdata.fda.gov |
| Apron, Protective | IWO | 1 | Exporter to the US | accessdata.fda.gov |
| Bag, Drainage, With Adhesive, Ostomy | FON | 1 | Exporter to the US | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Exporter to the US | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Exporter to the US | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Exporter to the US | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Exporter to the US | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Exporter to the US | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Exporter to the US | accessdata.fda.gov |
| Catheter, Infusion | JCY | 1 | Exporter to the US | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Exporter to the US | accessdata.fda.gov |
| Clamp | HXD | 1 | Exporter to the US | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Exporter to the US | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Exporter to the US | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Exporter to the US | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Exporter to the US | accessdata.fda.gov |
| Dish, Tissue Culture | KIZ | 1 | Exporter to the US | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Epilator, High Frequency, Tweezer-Type | KCX | 1 | Exporter to the US | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Exporter to the US | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Exporter to the US | accessdata.fda.gov |
| Forceps | HTD | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Exporter to the US | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Exporter to the US | accessdata.fda.gov |
| Hood, Oxygen, Infant | FOG | 1 | Exporter to the US | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Exporter to the US | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Exporter to the US | accessdata.fda.gov |
| Pad, Denture, Over The Counter | EHR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Exporter to the US | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Exporter to the US | accessdata.fda.gov |
| Sheet, Burn | FPY | 1 | Exporter to the US | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Exporter to the US | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Manufacturer | accessdata.fda.gov |
| Silicone Hydrogel For Scar Management | PFP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Exporter to the US | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Exporter to the US | accessdata.fda.gov |
| Stapler, Surgical | GAG | 2 | Exporter to the US | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Exporter to the US | accessdata.fda.gov |
| System, Skin Closure | MKY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | accessdata.fda.gov |
| Thermometer, Clinical Color Change | FQZ | 1 | Exporter to the US | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Exporter to the US | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Exporter to the US | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| November 17, 2017 | K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) | CBP | Substantially Equivalent | Xiamen Compower Medical Tech. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 17, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.