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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 29 of 30
DeviceModel / ReferenceRegistriesClassStatus
Precision IV Set, 250cm, Needle-Free Y Site 429180
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo 200-2-100h with Hanger Cap 475200HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 5ml Refill 60 min Single Hanger Cap&NRFit 487440HCN
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo 125-5-25h 475310
EUDAMED
Class IIaActive
SMARTeZ Plus-Chemo 65-0.5-130h 472020
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 2ml Refill 15 min Bifurcate Hanger Cap 479150HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed Flow 120-5-24h with Hanger Cap 483040HC
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 100ml-1ml/h-Bolus 5ml Refill 60 min Single, Hanger Cap 477530HC
EUDAMED
Class IIaActive
SMARTeZ Pump KVO 50-1-50h 498141
EUDAMED
Class IIaActive
ToxiSeal Vial Adaptor for 20 mm Vial 423130
EUDAMED
Class IActive
SMARTeZ RS-Chemo 48-2-24h with Hanger Cap 475010HC
EUDAMED
Class IIaActive
SMARTeZ Pump C120-5-24h 484290H
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 1-7ml/h Bolus 5 ml Refill 60 min Single NRFit 487420N
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo CS 270-5-54h with Hanger Cap 475670HC
EUDAMED
Class IIaActive
ProSeal BCG Kit 20 mm Vial 424180
EUDAMED
Class IActive
SMARTeZ Pump 120-4-30h (Transparent) 480060T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 100ml-2ml/h-Bolus 5ml Refill 30 min Single 477590
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 30 min Bifurcate 487300
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo 65-2.7-24h 475020
EUDAMED
Class IIaActive
Safety Subcutaneous Infusion Set 2 Needles, 24G, 9 mm, 40 cm Tube 418070
EUDAMED
Class IIbActive
ToxiSeal Vial Adaptor (DMA Compatible) for 28 mm Vial Concave 420445
EUDAMED
Class IActive
SMARTeZ RS-PainBloc-Variable Flow Volume 270ml flow 1-7ml/h NRFit 478030N
EUDAMED
Class IIaActive
SMARTeZ Plus-General Infusion 250-250-60m 471130
EUDAMED
Class IIaActive
SMARTeZ Pump 250-100-150m Light Protection 481128LP
EUDAMED
Class IIaActive
SMARTeZ Pump 60-1.5-40h 480340
EUDAMED
Class IIaActive
SMARTeZ Plus-General Infusion 500-250-2h with Hanger Cap 471140HC
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed Flow 600-5-120h with Hanger Cap & NRFit 483170HCN
EUDAMED
Class IIaActive
SMARTeZ Pump 48-2-24h (Transparent) 480660T
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 2ml Refill 15 min Bifurcate Hanger Cap 487180HC
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 1ml Refill 30 min Single 479020
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 5ml Refill 30 min Single with Hanger Cap 485300HC
EUDAMED
Class IIaActive
SMARTeZ Pump 400-4-100h (Transparent) 480140T
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow with Bolus 100ml-1ml/h-Bolus 1ml Refill 30 min with Hanger Cap & NRFit 477020HCN
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 1ml Refill 15 min Single Hanger Cap 487260HC
EUDAMED
Class IIaActive
SMARTeZ Plus-Chemo 270-10-27h 472130
EUDAMED
Class IIaActive
Vented Blood Administration Set, HiFlo Port, 195 cm 430150
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 120-10-12h NRFit 476180N
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 2ml Refill 60 min Single 487010
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 15 min Single NRFit 479110N
EUDAMED
Class IIaActive
SMARTeZ Pump C120-30-4h 484090
EUDAMED
Class IIaActive
SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 2ml Refill 60 min Single Hanger Cap 485240HC
EUDAMED
Class IIaActive
SMARTeZ Plus-Chemo 270-10-27h with Hanger Cap 472130HC
EUDAMED
Class IIaActive
ADRx Multi Dose No Vial Adaptor 428200
EUDAMED
Class IActive
SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 2-14ml/h Bolus 2ml Refill 15 min Single Hanger Cap&NRFit 487100HCN
EUDAMED
Class IIaActive
SMARTeZ Pump 200-25-8h 481250
EUDAMED
Class IIaActive
SMARTeZ Plus-General Infusion 200-200-60m with Hanger Cap 471110HC
EUDAMED
Class IIaActive
SMARTeZ RS-Chemo CS 250-2.1-119h with Hanger Cap 475640HC
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Fixed Flow Rate 120-4-30h 476110
EUDAMED
Class IIaActive
SMARTeZ RS-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 1ml Refill 30 min Single Hanger Cap 479020HC
EUDAMED
Class IIaActive
SMARTeZ Pump 240-10-24h 480260
EUDAMED
Class IIaActive

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