# Epic International (Thailand) Co., Ltd. (manufacturer, Amphur Pluakdaeng Rayong, TH): 6 new FDA device listings, incl. controller, infusion, intravascular, electronic

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Epic International (Thailand) Co., Ltd. |
| Owner / operator | Epic Medical Pte Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Amphur Pluakdaeng Rayong, TH |
| New listings | 6 |
| Devices | Controller, Infusion, Intravascular, Electronic; Set, Administration, Intravascular; Set, I.V. Fluid Transfer; Pump, Infusion, Elastomeric; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Product codes | LDR, FPA, LHI, MEB, ONB |
| Device classes | Class II |
| Medical specialties | General Hospital |
| Brand names | DOSI-FLOW; ADRx Admixture System; SMARTeZ RS; EZ IV Administration Set; ProSeal Transfer Injector |
| First new listing | 2026-07-28 |
| Latest new listing | 2026-09-10 |
| FDA registration number | 3012429465 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- 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.