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SMARTeZ Pump 480091

by Epic International(Thailand) Company Limited

Ref 480090

SMARTeZ Pump 480091 is a device classified as Class IIa in the EU and Class II in the US made by Epic International(Thailand) Company Limited, registered in EUDAMED on 25 May 2026 (Basic UDI-DI 88592991B001U4), cleared under FDA 510(k) K151650 on 4 Apr 2016 and listed in FDA GUDID since 4 Mar 2020 (UDI-DI 18859299100095), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151650

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88592991B001U4 Basic UDI-DI 18859299100095UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18859299100095 UDI-DI Date4 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151650 Date4 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88592991B001U4 registered 25 May 2026 Active
  • FDA 510(k) K151650 decided 4 Apr 2016 Active
  • FDA GUDID UDI-DI 18859299100095 listed 4 Mar 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151650
  2. Listed FDA GUDID 18859299100095
  3. Registered EUDAMED 88592991B001U4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SMARTeZ Pump 270-5-54h EUDAMED
SMARTeZ Pump GUDID
Generic name
Elastomeric infusion pump system
Device name
Elastomeric Pump
Model / reference
480090 EUDAMED
480091 GUDID
Primary DI / UDI-DI
18859299100095
Basic UDI-DI
88592991B001U4
510(k) Number
FDA product code
MEB
EMDN code
A05010101 Elastomeric systems - fixed flow w/o additional bolus
GMDN term
Elastomeric infusion pump system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5725
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
480090
GUDID
480091
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Elastomeric infusion pump system

Cleared under the same submission (K151650)

and 8 more cleared under K151650

Similar devices in this category

Other devices filed under ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS.

Other devices from Epic International(Thailand) Company Limited

See all devices from Epic International(Thailand) Company Limited →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)