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SMARTeZ Pump

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 480180

by Epic International(thailand) Company Limited

Identity

Trade Name
SMARTeZ Pump 100-0.5-200h EUDAMED
SMARTeZ Pump FDA UDI
Generic Name
Elastomeric infusion pump system FDA UDI
Device Name
Elastomeric Pump EUDAMED
SMARTeZ Pump 100-0.5-200h FDA UDI
Model / Reference
480180 EUDAMED
480181 FDA UDI
Description
SMARTeZ Pump 100-0.5-200h FDA UDI

Identifiers

Primary DI / UDI-DI
18859299100187 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
Market of Registration
Portugal EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

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.

Cleared under the same submission

K151650 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epic International(thailand) Company Limited

Sources (2)

  • FDA UDI 1532de47-faae-4251-aad0-c276cdd6881b 34 fields · synced Jun 19, 2026
  • EUDAMED d2f08acc-7891-42d2-9a58-9ad05603713d 61 fields · synced Jun 19, 2026