FDA Registration
Active
🇨🇳 China
Nanjing J SUN Healthcare Co.,Ltd
Reg #: 3011529314
·
FEI: 3011529314
·
Expires 2026
Products
56
Proprietary Names
72
Establishment Types
3
Classifications
56
Registration Details
- Registration Name
- Nanjing J SUN Healthcare Co.,Ltd
- Registration Number
- 3011529314
- FEI Number
- 3011529314
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 1, Sanjiangkou Industrial Park, Jing'an, Qixia District
- City
- Nanjing Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171961
Owner / Operator
- Firm Name
- Nanjing J SUN Healthcare Co.,Ltd
- Operator Number
- 10057025
- Address
- No. 1, Sanjiangkou Industrial Park, Jing'an, Qixia District
- City
- Nanjing
- State
- Jiangsu
- Postal Code
- 210009
- Country
- CN
US Agent
- Business Name
- FDAbasics
- Contact Name
- Emily Matorin
- Address
- 1 Prospect Park West Ste 4D
- City
- Brooklyn
- State
- NY
- ZIP
- 11215
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2018-02-12 |
| Pad, Denture, Over The Counter | EHR | Class 2 | Dental | No | 2022-11-04 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2018-02-12 |
| Hood, Oxygen, Infant | FOG | Class 1 | Anesthesiology | No | 2020-03-23 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2018-02-12 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2018-02-12 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2018-02-12 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2018-03-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2018-03-07 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-04-15 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2018-03-07 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2019-11-04 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2018-03-07 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2018-08-31 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-23 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2018-02-12 |
| Silicone Hydrogel For Scar Management | PFP | Class 1 | General, Plastic Surgery | No | 2022-11-02 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2022-11-02 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2020-06-07 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2018-02-12 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2018-03-15 |
| Epilator, High Frequency, Tweezer-Type | KCX | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2018-03-07 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2023-05-19 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2018-03-07 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-03-23 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2018-02-12 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2020-05-18 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2018-02-12 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2020-04-14 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2018-03-07 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2018-03-07 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2018-02-12 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2018-02-12 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2018-03-07 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 2018-03-07 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2018-03-07 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2018-03-07 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2018-02-12 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2018-03-07 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2022-11-02 |
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
Sterile compression dressing
external
extremity,
splint
non-sterile
non-inflatable
Airway, oropharyngeal,anesthesiology
SUIT, SURGICAL
Infusion catheter
DRESS, SURGICAL
Tourniquet
Arm Sling / triangular bandage
Shoe cover
CAP, SURGICAL
Clinical thermometer
non-surgical isolation gown
Yankauer Sauction Instrument with Thumb control hole
Suction Catheter and tip
Stickers with Tea Tree Oil and Calendula Oil
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
Hellados 450 Pimple Patches For Face, 4 Size Acne Patches, Hydrocolloid Zit Patches, Blemish Patches, Spot
Pad, Eye
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Manufacture Medical Device