Data / Medical devices / Thailand / Epic International (Thailand) Co., Ltd.
Epic International (Thailand) Co., Ltd.: FDA-registered device maker in Amphur Pluakdaeng Rayong, Thailand, 23 510(k) clearances
Epic International (Thailand) Co., Ltd. is registered with the FDA (registration 3012429465) in Amphur Pluakdaeng Rayong, Thailand. It lists 8 device types. The FDA files 23 510(k) clearances under its listings, the newest dated June 12, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012429465
- Address
- WHA Eastern Seaboard Industrial Estate 1 500/73 Moo 2, Tambon Tasit, Amphur Pluakdaeng Rayong, Thailand, 21140
- Owner or operator
- Epic Medical Pte Ltd (10051573)
- Roles
- Manufacturer
- First device listed
- April 5, 2016
- Registered through
- 2027
- Brand names listed
- ADRx Admixture System, DOSI-FLOW, DOSI-FUSER, EZ IV Administration Set, EZ-FLOW, MEDI-FLO, McKesson, ProSeal Bag Spike with Additive Port and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Manufacturer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Manufacturer | accessdata.fda.gov |
| Controller, Infusion, Intravascular, Electronic | LDR | 2 | Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Elastomeric | MEB | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| System/Device, Pharmacy Compounding | NEP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2026 | K252987 | ADRx Admixture Device | LHI | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| April 24, 2026 | K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) | MEB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| December 5, 2025 | K251722 | ProSeal Transfer Injector (421120, 421130, 421140) | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| August 29, 2025 | K251814 | EZ IV Administration Set | FPA | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| August 1, 2025 | K252094 | eZSURE Empty Fluid Container | KPE | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| May 29, 2025 | K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| December 26, 2024 | K240517 | ProSeal Vented Universal Vial Adaptor | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| October 23, 2024 | K241988 | ProSeal Closed System Bag Access | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| October 10, 2024 | K241735 | ProSeal In Line Pump Set (423850) | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| October 7, 2024 | K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | MEB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| August 30, 2024 | K241823 | ToxiSeal Vial Adaptor | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| June 21, 2024 | K241476 | ToxiSeal Vial Adaptor with External Flip Balloon | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| June 21, 2024 | K241442 | eZSURE Empty Fluid Container with ProSeal Injection Site | KPE | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| May 21, 2024 | K240433 | ProSeal Injection Site Extended Male Luer Lock (422140) | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| March 28, 2024 | K240171 | ProSeal Injector Plus (Model no. 421050) | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| November 3, 2023 | K230343 | ProSeal Closed System Administration Set | FPA | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| September 1, 2023 | K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110) | KPE | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| March 24, 2021 | K201626 | Safety Subcutaneous Infusion Set | FPA | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| August 7, 2020 | K192075 | ProSeal Closed System drug Transfer Device (CSTD) | ONB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| April 4, 2016 | K151650 | SMARTez elastomeric infusion pump | MEB | Substantially Equivalent | Epic Medical Pte. , Ltd. | accessdata.fda.gov |
| April 7, 2004 | K040752 | DOSI-FUSER | MEB | Substantially Equivalent | Leventon, S.A. | accessdata.fda.gov |
| September 8, 1995 | K952810 | DOSI-FLOW, MODELS 20 & 30 | FPA | Substantially Equivalent | Leventon, S.A. | accessdata.fda.gov |
| April 29, 1985 | K851058 | DOSI FLOW | LDR | Substantially Equivalent | Leventon, S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Controller, Infusion, Intravascular, Electronic
- All makers of Set, Administration, Intravascular
- All makers of Set, I.V. Fluid Transfer
- All makers of Container, I.V.
- All makers of Pump, Infusion, Elastomeric
Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.