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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 27 of 30
DeviceModel / ReferenceRegistriesClassStatus
SMARTeZ Pump 275-2.5-110h 480420
EUDAMED
Class IIaActive
SMARTeZ Pump CS 65-0.5-130h 484520
EUDAMED
Class IIaActive
SMARTeZ Pump 275-3.5-79h (Transparent) 480550T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 100ml flow 2-14ml/h Bolus 2ml Refill 60 min Single NRFit 479190N
EUDAMED
Class IIaActive
Safety Subcutaneous Infusion Set 4 Needles, 26G, 9 mm, 40 cm Tube 418220
EUDAMED
Class IIbActive
SMARTeZ Plus-PainBloc-Fixed Flow 400-5-80h with Hanger Cap & NRFit 483130HCN
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 270ml-4ml/h-Bolus 2ml Refill 30 min Bifurcated 485250
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Flow Selector-Volume 100 ml flow rate 0/2/4/6/8/10/12/14ml/h, Hanger Cap 478520HC
EUDAMED
Class IIaActive
ToxiSeal Universal Vial Adaptor with External Balloon 420840
EUDAMED
Class IActive
Safety Subcutaneous Infusion Set 1 Needle, 24G, 6 mm, 80 cm Tube 418360
EUDAMED
Class IIbActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 100ml-1ml/h-Bolus 2ml Refill 60 min NRFit 477060N
EUDAMED
Class IIaActive
SMARTeZ Pump 100-2-50h (Transparent) 480080T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 120-10-12h 476180
EUDAMED
Class IIaActive
Blood Administration Set, Non-Vented, Multiflow, Hand Pump, x2 HiFlo Ports, 300 cm 430050
EUDAMED
Class IIaActive
SMARTeZ Pump 250-125-120m (Transparent) 481130T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 100-4-25h with Hanger Cap 476200HC
EUDAMED
Class IIaActive
SMARTeZ RS-General Infusion 270-2-135h with Hanger Cap 474180HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow Volume 400ml flow Dual 1-7 ml/h with Hanger Cap 486090HC
EUDAMED
Class IIaActive
SMARTeZ Pump 275-3.5-79h 480550
EUDAMED
Class IIaActive
ToxiSeal Vial Adaptor (DMA Compatible) for 28 mm Vial 420350
EUDAMED
Class IActive
SMARTeZ Pump 250-1.5-167h 480290
EUDAMED
Class IIaActive
SMARTeZ Plus-General Infusion 200-100-2h 471050
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo 100-50-2-h 475300
EUDAMED
Class IIaActive
SMARTeZ Pump 275-2-138h 480520
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 2ml Refill 60 min Single Hanger Cap & NRFit 479200HCN
EUDAMED
Class IIaActive
SMARTeZ RS-General Infusion 250-2.1-119h with Hanger Cap 474350HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 15 min Single Hanger Cap&NRFit 487140HCN
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 60-5-12h NRFit 476130N
EUDAMED
Class IIaActive
ToxiSeal Vial Adaptor (DMA Compatible) for 13 mm Vial 420330
EUDAMED
Class IActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 100-2-50h with Hanger Cap & NRFit 476070HCN
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 5ml Refill 30 min Single Hanger Cap 487530HC
EUDAMED
Class IIaActive
51 cm (20") Quadfuse Add-On Set w/3 ProSeal Injector, x4 Clamps, w/Twist-off port 423330
EUDAMED
Class IActive
SMARTeZ Plus-PainBloc-Fixed Flow 60-5-12h with NRFit 483010N
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 30 min Single Hanger Cap 487290HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 600ml flow 2-14ml/h Bolus 5ml Refill 30 min Single 487490
EUDAMED
Class IIaActive
SMARTeZ Pump 400-200-120m Light Protection 481070LP
EUDAMED
Class IIaActive
SMARTeZ Pump 120-30-4h (Transparent) 481220T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 100ml-2ml/h-Bolus 5ml Refill 15 min Single 477570
EUDAMED
Class IIaActive
SMARTeZ Pump 270-4-68h (Transparent) 480130T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Flow Selector-Volume 100 ml flow rate 0/2/4/6/8/10/12/14ml/h, NRFit 478520N
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 120ml-1ml/h-Bolus 1ml Refill 15 min 477150
EUDAMED
Class IIaActive
EZ IV Administration set, 240 cm (96"), Vented spike 20 drops/mL, 2 NFV Ports, Rotating Male Luer Lock 429150
EUDAMED
Class IActive
Closed System Priming Cap Gravity feed 423270
EUDAMED
Class IActive
SMARTeZ RS-Chemo CS 120-5-24h with Hanger Cap 475570HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-4ml/h-Bolus 2ml Refill 15 min Single Hanger Cap&NRFit 485150HCN
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 100ml-1ml/h-Bolus 2ml Refill 60 min Single 485060
EUDAMED
Class IIaActive
SMARTeZ Pump 250-250-60m (Transparent) 481050T
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed Flow 100-1-100h 483020
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 600ml flow 2-14ml/h Bolus 2ml Refill 15 min Bifurcate Hanger Cap 487370HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 2ml Refill 30 min Single Hanger Cap 487190HC
EUDAMED
Class IIaActive

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