Data / Medical devices / China / Shanghai Neo-Medical Import & Export Co., Ltd.
Shanghai Neo-Medical Import & Export Co., Ltd.: FDA-registered device maker in Shanghai, China, 4 510(k) clearances
Shanghai Neo-Medical Import & Export Co., Ltd. is registered with the FDA (registration 3005327291) in Shanghai, China. It lists 59 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 14, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005327291
- Address
- Rm2004 B/D3,183 Huaihai xi Rd, Shanghai, China, 200030
- Owner or operator
- SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. (9078839)
- Roles
- Exporter to the US
- First device listed
- October 24, 2005
- Registered through
- 2026
- Brand names listed
- Adhesive Bandage, Air Cushion, Alcohol Prep Pad, Applicator, BEDPAN, Breast Pump, CAP, COLOSTOMY BAG and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Adaptor, Ureteral Catheter | EYI | 1 | Exporter to the US | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Exporter to the US | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Exporter to the US | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Exporter to the US | accessdata.fda.gov |
| Applicator, Ent | KCJ | 1 | Exporter to the US | accessdata.fda.gov |
| Bag, Drainage, With Adhesive, Ostomy | FON | 1 | Exporter to the US | accessdata.fda.gov |
| Bag, Ice | KYR | 1 | Exporter to the US | accessdata.fda.gov |
| Bag, Urine Collecting, Ureterostomy | EXG | 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 |
| Bedpan | FOB | 1 | Exporter to the US | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Exporter to the US | accessdata.fda.gov |
| Bottle, Hot/Cold Water | FPF | 1 | Exporter to the US | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 1 | Exporter to the US | accessdata.fda.gov |
| Cannula, Injection | FGY | 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, Infusion | JCY | 1 | Exporter to the US | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Exporter to the US | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 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 |
| Coverslips, Microscope Slide | KES | 1 | Exporter to the US | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Exporter to the US | accessdata.fda.gov |
| Depressor, Metal Tongue, Surgical | KBL | 1 | Exporter to the US | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Exporter to the US | accessdata.fda.gov |
| Device, Occlusion, Umbilical | FOD | 1 | Exporter to the US | accessdata.fda.gov |
| Dish, Tissue Culture | KIZ | 1 | Exporter to the US | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Exporter to the US | accessdata.fda.gov |
| Douche Apparatus, Vaginal, Therapeutic | HED | 1 | Exporter to the US | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Exporter to the US | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Exporter to the US | accessdata.fda.gov |
| Excavator, Ear | JYH | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Exporter to the US | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Exporter to the US | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Exporter to the US | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Exporter to the US | accessdata.fda.gov |
| Pouch, Colostomy | EZQ | 1 | Exporter to the US | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Exporter to the US | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Exporter to the US | accessdata.fda.gov |
| Spatula, Cervical, Cytological | HHT | 2 | Exporter to the US | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Exporter to the US | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Exporter to the US | accessdata.fda.gov |
| Stocking, Elastic | ILG | 1 | Exporter to the US | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Exporter to the US | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Exporter to the US | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Exporter to the US | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | accessdata.fda.gov |
| Topical Approximation System | MZR | 1 | Exporter to the US | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Exporter to the US | accessdata.fda.gov |
| Trap, Sterile Specimen | BYZ | 2 | Exporter to the US | accessdata.fda.gov |
| Urinal | FNP | 1 | 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 |
|---|
| February 14, 2017 | K162590 | Bashan TDP Heat Lamp | ILY | Substantially Equivalent | Chogqing Yuhe Medical Instruments Co., Ltd. | accessdata.fda.gov |
| September 16, 2011 | K111559 | SURGICAL MASKS | FXX | Substantially Equivalent | Shanghai Neo-Medical Import & Export Co., Ltd. | accessdata.fda.gov |
| September 15, 2004 | K041954 | DISPOSABLE MONITORING ELECTRODES | DRX | Substantially Equivalent | Shanghai Intco Electrode Manufacturing Co., Ltd. | accessdata.fda.gov |
| July 25, 1995 | K950780 | AMSINO CERVICAL SCRAPER | HHT | Substantially Equivalent | Amsino Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Device, Occlusion, Umbilical
- All makers of Bag, Drainage, With Adhesive, Ostomy
- All makers of Pad, Eye
- All makers of Tape And Bandage, Adhesive
- All makers of Urinal
Updated February 14, 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.