# Astron Medtech Co., Ltd. (repackager or relabeler, Taipei, TW): 5 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Astron Medtech Co., Ltd. |
| Role | Repackager or relabeler |
| Establishment types | Foreign Private Label Distributor; Repack or Relabel Medical Device |
| Location | Taipei, TW |
| New listings | 5 |
| Devices | Suture, Nonabsorbable, Synthetic, Polyethylene; Fastener, Fixation, Nondegradable, Soft Tissue; Accessories, Arthroscopic; Orthopedic Manual Surgical Instrument |
| Product codes | GAT, MBI, NBH, LXH |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic |
| Brand names | TendMIN ® Suture Kit - Loop Suture; TendMIN ® Anchor Kit - Anchor; TendMIN ® Anchor Kit - Passer; TendMIN ® Suture Kit - Suture Tape; TendMIN ® Suture Kit - Grasper, Telescoping Needle |
| First new listing | 2026-06-26 |
| Latest new listing | 2026-07-03 |
| FDA registration number | 3044423486 |
| 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: 2026-10-28T20:51:27.468Z.
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.