Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012429465

FEI Number

3012429465

Entity Name

Epic International (Thailand) Co., Ltd.

City/State/Country

Pluak Daeng Rayong, TH

Establishment Address

Hemaraj Eastern Seaboard Industrial Estate, 500/73 Moo 2, Tasit, Pluak Daeng Rayong 21140, TH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Epic Medical Pte Ltd (Owner Number: 10051573)

Owner / Operator Contact Address

105 Cecil Street #20-01, The Octagon, Singapore, SG-01 069534, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240517

PMA Number

N/A

All Registered Proprietary Names

ProSeal Closed System Bag Access SMARTeZ Pump McKesson EZ-FLOW SimplFusor MEDI-FLO eZSURE Empty Fluid Container Safety Subcutaneous Infusion Set ProSeal Injection Site Extended Male Luer Lock SMARTeZ Pump ProSeal Closed System Administration Set RxBot Peristaltic Pump Set, RxFill Tube Set eZSURE SMARTeZ Fluid Transfer Set SMARTeZ Pharmacy Filling Pump RxFill RxBot DOSI-FUSER ToxiSeal Vial Adaptor with External Flip Balloon ProSeal Injector Plus ProSeal Bag Spike with Additive Port

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-08-25
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-08-25
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2016-04-05
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2025-05-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-11-15
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-08-25
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2025-08-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-25
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2017-12-13
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2018-02-01
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2025-02-25
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-08-25
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-08-25
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-08-25
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2025-12-31
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-12-31
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-12-31
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-12-31
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-12-31

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: REGISTRAR CORP Email: David.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Epic Medical Pte Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0004-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012429465. Last updated year: 2026. Please use registration number 3012429465 when referencing this establishment in official correspondence.