# Paragon Medical Device (Changzhou) Co., Ltd. (contract manufacturer, Changzhou Jiangsu, CN): 5 new FDA device listings, incl. stripper, surgical

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Paragon Medical Device (Changzhou) Co., Ltd. |
| Owner / operator | Paragon Medical |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Changzhou Jiangsu, CN |
| New listings | 5 |
| Devices | Stripper, Surgical; Elevator; Orthopedic Stereotaxic Instrument; Handle, Scalpel; Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Product codes | HRT, HTE, OLO, GDZ, HBE |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery, Neurology |
| Brand names | VersiQuad Tendon Cutter; 3MM DRILL BIT, MEDIUM; RG 6.5 CORTICAL TAP SHORT; RG 5.5 CORTICAL TAP SHORT; RG 5.5 CORTICAL TAP LONG; RG 6.5 CORTICAL TAP LONG; RG 7.5 CORTICAL TAP SHORT; RG 7.5 CORTICAL TAP LONG |
| First new listing | 2026-08-18 |
| Latest new listing | 2026-09-29 |
| FDA registration number | 3007539489 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

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.