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Epic International (Thailand) Co., Ltd.

Thailand·TH-MF-000012102

Last updated September 17, 2026

About

Epic Medical offers a wide range of innovative medical products that improve healthcare delivery standards and quality of life for patients.

From the manufacturer's own website. Source

What Epic International (Thailand) Co., Ltd. makes

Epic International (Thailand) manufactures elastomeric infusion pumps, including fixed-flow and programmable models like the SMARTeZ series, designed for continuous or bolus drug delivery. Their portfolio also includes intravenous administration bags and bottles, such as the SMARTeZ Plus variants, as well as specialized connectors like the ProSeal ChemoSafe for closed-system chemotherapy administration. Additional products include BCG and ADRx single-dose vials for intravesical therapy.

The company’s devices are classified under EU regulations as Class I, Class IIa, and Class IIb, with listings in the EU’s eudamed database. The manufacturer is based in Thailand.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Epic International (Thailand) Co., Ltd. manufacture?

Epic International (Thailand) Co., Ltd. specializes in elastomeric infusion pump systems and intravenous administration products. Their elastomeric pumps, like the SMARTeZ series, are designed for continuous or bolus drug delivery, including fixed-flow and programmable models. They also produce intravenous administration bags and bottles, such as the SMARTeZ Plus variants, as well as specialized connectors like the ProSeal ChemoSafe for closed-system chemotherapy administration. Their portfolio also includes single-dose vials for intravesical therapy, such as BCG and ADRx kits.

Where is Epic International (Thailand) Co., Ltd. based?

The company is headquartered in Thailand, as indicated by its name and regulatory information.

Which regulatory registries list Epic International (Thailand) Co., Ltd.’s devices?

Epic International (Thailand) Co., Ltd.’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used to track manufacturers and their products under EU regulations.

How are Epic International (Thailand) Co., Ltd.’s devices classified under EU regulations?

The company’s devices fall into three classification categories under EU regulations: Class I (typically low-risk devices), Class IIa (moderate-risk devices requiring additional safety measures), and Class IIb (higher-risk devices requiring stringent controls, such as infusion pumps and specialized connectors). Classification depends on factors like intended use, duration of contact with the body, and potential risks.

What distinguishes Epic International (Thailand) Co., Ltd.’s elastomeric infusion pumps from other infusion systems?

Epic’s elastomeric infusion pumps, such as the SMARTeZ series, are designed for portable, continuous drug delivery without the need for external power sources, unlike traditional electric infusion pumps. They use compressed elastomer chambers to deliver medication at fixed or programmable rates, making them suitable for outpatient or home use. Some models, like the SMARTeZ Plus variants, also include features like bolus functionality or specialized flow rates for targeted therapies, such as pain management or chemotherapy administration.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Thailand
Address
WHA Eastern Seaboard Industrial Estate 1, Rayong, Thailand
Facebook
—
Phone
+65 62212660
PRRC Contact
Hao Sun
EUDAMED SRN
TH-MF-000012102
FDA FEI Number
3012429465
DUNS Number
—

Catalogue (1465)

Page 5 of 30
DeviceModel / ReferenceRegistriesClassStatus
SMARTeZ RS-General Infusion 100-8-12.5h 474190
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 100ml-2ml/h-Bolus 5ml Refill 15 min Single, Hanger Cap & NRFit 477570HCN
EUDAMED
Class IIaActive
SMARTeZ Plus-General Infusion 100-200-30m 471100
EUDAMED
Class IIaActive
Safety Subcutaneous Infusion Set 1 Needle, 24G, 12 mm, 80 cm Tube 418380
EUDAMED
Class IIbActive
SMARTeZ Pump 500-250-120m (Transparent) 481080T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 100ml-1ml/h-Bolus 5ml Refill 30 min Single 477520
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-6ml/h-Bolus 2ml Refill 15 min Single 485170
EUDAMED
Class IIaActive
ProSeal Universal Non-Vented Bag Spike 423940
EUDAMED
Class IActive
ProSeal ClickSafe Non-Vented Bag Spike 423650ST
EUDAMED
Class IActive
SMARTeZ RS-General Infusion 400-8.3-48h 474460
EUDAMED
Class IIaActive
ProSeal Non Vented Bag Spike (NFV Outlet) 423100
EUDAMED
Class IActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 600ml flow 2-14ml/h Bolus 2ml Refill 60 min Single Hanger Cap 487400HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed Flow 400-5-80h with NRFit 483130N
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-6ml/h-Bolus 2ml Refill 15 min Single Hanger Cap&NRFit 485170HCN
EUDAMED
Class IIaActive
Safety Subcutaneous Infusion Set 2 Needles, 26G, 9 mm, 40 cm Tube 418100
EUDAMED
Class IIbActive
Safety Subcutaneous Infusion Set 1 Needle, 26G, 9 mm, 40 cm Tube 418010
EUDAMED
Class IIbActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 2ml Refill 30 min bifurcate 479040
EUDAMED
Class IIaActive
SMARTeZ Pump C100-5-20h (Transparent) 484260T
EUDAMED
Class IIaActive
SMARTeZ Pump CS 240-5-48h (Transparent) 484530T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 48-2-24h with Hanger Cap & NRFit 476050HCN
EUDAMED
Class IIaActive
SMARTeZ Plus-Chemo 240-5-48h 472110
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 600ml flow 2-14ml/h Bolus 2ml Refill 30 min Single NRFit 487380N
EUDAMED
Class IIaActive
SMARTeZ Plus-Chemo 60-2-30h 472050
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 1ml Refill 15 min Single Hanger Cap 479010HC
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow Volume 300ml flow 2-14ml/h Hanger Cap & NRFit 478090HCN
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed Flow 100-2-50h 483030
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo 270-2-135h with Hanger Cap 475180HC
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 270-4-68h 476120
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 270-10-27h with Hanger Cap & NRFit 476190HCN
EUDAMED
Class IIaActive
Safety Subcutaneous Infusion Set 2 Needles, 26G, 12 mm, 80 cm Tube 418310
EUDAMED
Class IIbActive
SMARTeZ Pump KVO 50-0.5-100h 498130
EUDAMED
Class IIaActive
SMARTeZ Pump 500-40-12.5h 481180
EUDAMED
Class IIaActive
SMARTeZ Pump C240-10-24h (Transparent) 484080T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 270-10-27h with Hanger Cap 476190HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 60 min Single Hanger Cap 487250HC
EUDAMED
Class IIaActive
Extension Set Bifurcated 2.35 mm Length 15 cm with 2 NFV Connector and Rotating Luer 423540
EUDAMED
Class IActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 30 min Single 487020
EUDAMED
Class IIaActive
SMARTeZ RS-General Infusion 100-50-2h with Hanger Cap 474020HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 100ml-2ml/h-Bolus 2ml Refill 30 min Single 485090
EUDAMED
Class IIaActive
Syringe Perfusion, 50ml 432010
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 60 min Single Hanger Cap&NRFit 487250HCN
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Flow Selector-Volume 400 ml flow rate 0/2/4/6/8/10/12/14ml/h, Hanger Cap NRFIt 478560HCN
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 270ml-5ml/h-Bolus 5ml Refill 30 min Single, Hanger Cap & NRFit 477650HCN
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 270ml-2ml/h-Bolus 1ml Refill 15 min with Hanger Cap & NRFit 477100HCN
EUDAMED
Class IIaActive
SMARTeZ Plus-Chemo CS 270-5-54h with Hanger Cap 472600HC
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Flobot Flow Selector and Bolus-Volume 270 ml flow rate 0/1/2/3/4/5/6/7 ml/h Bolus 5 ml Refill 30 min, Single 479600
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 1-7ml/h Bolus 5ml Refill 60 min Single Hanger Cap&NRFit 487420HCN
EUDAMED
Class IIaActive
SMARTeZ Pump 85-0.5-170h 480300
EUDAMED
Class IIaActive
SMARTeZ Pump 100-1-100h (Transparent) 480310T
EUDAMED
Class IIaActive
SMARTeZ Plus-General Infusion 1000-80-12.5h with Hanger Cap 471220HC
EUDAMED
Class IIaActive

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