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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
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Catalogue (1465)

Page 3 of 30
DeviceModel / ReferenceRegistriesClassStatus
SMARTeZ RS-PainBloc-Fixed Flow Rate 120-4-30h NRFit 476110N
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Flobot Flow Selector and Bolus-Volume 100 ml flow rate 0/1/2/3/4/5/6/7 ml/h Bolus 5 ml Refill 30 min, Single, NRFit 479520N
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 30 min Bifurcate NRFit 479120N
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed Flow 400-8-50h with Hanger Cap 483150HC
EUDAMED
Class IIaActive
SMARTeZ RS-General Infusion 250-1.5-167h with Hanger Cap 474370HC
EUDAMED
Class IIaActive
SMARTeZ RS-General Infusion 250-250-60m 474110
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed Flow Volume 400ml Flow Rate Dual 2ml/h with Hanger Cap & NRFit 483210HCN
EUDAMED
Class IIaActive
SMARTeZ Pump C50-2-25h (Transparent) 484060T
EUDAMED
Class IIaActive
ProSeal Vented Vial Adaptor for 20 - 28 mm Vial 420680ST
EUDAMED
Class IActive
SMARTeZ Plus-General Infusion 60-2.5-24h 471170
EUDAMED
Class IIaActive
SMARTeZ Plus-Chemo 50-2-25h 472040
EUDAMED
Class IIaActive
Safety Subcutaneous Infusion Set 2 Needles, 26G, 6 mm, 40 cm Tube 418090
EUDAMED
Class IIbActive
Vented Blood Administration Set, Hand Pump, x3 HiFlo Ports, Luer break, 260cm 430010
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 600ml flow 2-14ml/h Bolus 2ml Refill 15 min Single Hanger Cap&NRFit 487360HCN
EUDAMED
Class IIaActive
SMARTeZ RS-General Infusion 200-100-2h with Hanger Cap 474050HC
EUDAMED
Class IIaActive
ProSeal NFV Hi-Flo Valve 422150
EUDAMED
Class IActive
ProSeal ClickSafe Vial Adaptor with External Flip Balloon (DMA Compatible) 13 mm Vial 420930
EUDAMED
Class IActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 1ml Refill 30 min Single Hanger Cap & NRFit 479180HCN
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo CS 96-2-48h with Hanger Cap 475530HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed Flow 240-10-24h 483070
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed Flow Volume 400ml Flow Rate Dual 2+2ml/h 483210
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 600ml flow 2-14ml/h Bolus 5ml Refill 30 min Single Hanger Cap&NRFit 487490HCN
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-8ml/h-Bolus 2ml Refill 15 min Single Hanger Cap&NRFit 485180HCN
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 270ml-2ml/h-Bolus 5ml Refill 30 min Single, NRFit 477620N
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-2ml/h-Bolus 2ml Refill 30 min Single Hanger Cap&NRFit 485230HCN
EUDAMED
Class IIaActive
SMARTeZ Pump CS 50-2-25h (Transparent) 484450T
EUDAMED
Class IIaActive
SMARTeZ RS-General Infusion 240-2-120h with Hanger Cap 474480HC
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 100ml-2ml/h-Bolus 2ml Refill 15 min Hanger Cap 477080HC
EUDAMED
Class IIaActive
Administration Set, Non-Vented Drip Chamber, 180 cm, 0.2 µm In Line Filter, Rotating MLL 429420
EUDAMED
Class IActive
SMARTeZ Plus-PainBloc-Fixed Flow Volume 400ml Flow Rate Dual 2ml/h with Hanger Cap 483210HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 5ml Refill 60 min Single Hanger Cap&NRFit 487500HCN
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 270ml-2ml/h-Bolus 2ml Refill 15 min with Hanger Cap & NRFit 477110HCN
EUDAMED
Class IIaActive
SMARTeZ Pump 250-175-90m 481060
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 100ml-2ml/h-Bolus 2ml Refill 30 min Hanger Cap 477090HC
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 100ml flow 2-14ml/h Bolus 2ml Refill 15 min Single Hanger Cap & NRFit 479070HCN
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow Volume 100ml flow 1-7ml/h NRFit 478010N
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 60 min Single 487250
EUDAMED
Class IIaActive
ToxiSeal Vial Adaptor with External Balloon 20 - 28 mm Vial 420670
EUDAMED
Class IActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 60 min Single NRFit 487250N
EUDAMED
Class IIaActive
ProSeal Closed System Transfer Syringe, 50 ml 423710
EUDAMED
Class IActive
SMARTeZ Pump 270-175-90m (Transparent) 481230T
EUDAMED
Class IIaActive
SMARTeZ Plus-Chemo CS 240-2-120h 472570
EUDAMED
Class IIaActive
SMARTeZ Pump 60-2.5-24h 480280
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-5ml/h-Bolus 5ml Refill 15 min Single with Hanger Cap 485340HC
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo 65-130-30m 475290
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo 120-2.5-48h 475240
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 400ml-4ml/h-Bolus 2ml Refill 15 min Single Hanger Cap 485150HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 30 min Single 487290
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 120-10-12h with Hanger Cap & NRFit 476180HCN
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 100-4-25h 476200
EUDAMED
Class IIaActive

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