# Jiangsu New Pentastar Medical Products Co. Ltd. (foreign exporter, Changzhou Jiangsu, CN): 13 new FDA device listings, incl. cup, prophylaxis

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Jiangsu New Pentastar Medical Products Co. Ltd. |
| Owner / operator | New Pentastar Medical Products Co. Limited |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Changzhou Jiangsu, CN |
| New listings | 13 |
| Devices | Cup, Prophylaxis; Wrap, Sterilization; First Aid Kit With Drug; Catheter Care Tray; Chamber, Slide Culture; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Cover, Shoe, Operating-Room; Holder, Ureteral Catheter; Container, Sharps; System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Product codes | EHK, FRG, LRR, OHR, KIY, FMK, FXP, EYJ, MMK, EYZ, KTC, IWO, LRS |
| Device classes | Class I, Class II, Not classified |
| Medical specialties | Dental, General Hospital, Gastroenterology, Urology, Hematology, General, Plastic Surgery, Physical Medicine, Radiology |
| Brand names | Dental cup, Denture Cup; Sterilization Wrap, Autoclave Wrap; first aid kit with drug; Catheter Care Tray; chamber, slide culture; Safety lancet,; Boot Cover; Disposable Slipper; Shoe Cover; Sleeve Cover; Massage Slippers; socks |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-09-03 |
| FDA registration number | 3015058854 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.