# New Deantronics Taiwan Ltd. (contract manufacturer, New Taipei City, TW): 3 new FDA device listings, incl. appliance, fixation, nail/blade/plate combination, multiple component

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | New Deantronics Taiwan Ltd. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device |
| Location | New Taipei City, TW |
| New listings | 3 |
| Devices | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Software For Diagnosis/Treatment; Electrosurgical, Cutting & Coagulation & Accessories |
| Product codes | KTT, OSN, GEI |
| Device classes | Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery |
| First new listing | 2026-05-18 |
| Latest new listing | 2026-06-17 |
| FDA registration number | 9681191 |
| 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.

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.
