SMARTeZ Pump

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 480130

by Epic International(thailand) Company Limited

Identity

Trade Name: SMARTeZ Pump 270-4-68h EUDAMED
SMARTeZ Pump FDA UDI
Generic Name: Elastomeric infusion pump system FDA UDI
Device Name: Elastomeric Pump EUDAMED
SMARTeZ Pump 270-4-68h FDA UDI
Model / Reference: 480130 EUDAMED
480131 FDA UDI
Description: SMARTeZ Pump 270-4-68h FDA UDI

Identifiers

Primary DI / UDI-DI: 18859299100132 EUDAMEDFDA UDI
Basic UDI-DI: 88592991B001U4 EUDAMED
510(k) Number: K151650 FDA UDI
FDA Product Code: MEB FDA UDI
EMDN Code: A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
GMDN Term: Elastomeric infusion pump system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Elastomeric infusion pump system

SMARTeZ Pump by Epic International(thailand) Company Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Elastomeric infusion pump system.

SMARTeZ Plus-PainBloc-Fixed Flow 240-10-24h — Epic International (Thailand) Co., Ltd. · Class IIa
Elastomeric Infusion Pump — Poly Medicure Limited · Class IIb
SMARTeZ RS-General Infusion 250-500-30m with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
Neofuser Twin — S&S Med Co.,Ltd. · Class IIb
Halyard — Avanos Medical, Inc. · Class II
SMARTeZ RS-PainBloc-Fixed Flow Rate 120-5-24h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
SMARTeZ Pump 500-40-12.5h — Epic International (Thailand) Co., Ltd. · Class IIa
Halyard — Avanos Medical, Inc. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Epic International(thailand) Company Limited

Sources (2)

FDA UDI 000af100-8671-4ecf-9f4f-a65abb259a18 34 fields · synced Jun 19, 2026
EUDAMED 037a94d4-384f-47c4-ac82-91a8a2b39c22 61 fields · synced Jun 14, 2026

SMARTeZ Pump

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

Manufacturer

Sources (2)