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SMARTeZ Plus-PainBloc-Fixed flow rate with Bolus 600ml-5ml/h-Bolus 5ml Refill 15 min Single with NRFit

by Epic International (Thailand) Co., Ltd.

Ref 485350N

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88592991B001U4 Basic UDI-DI 18859299121243UDI-DIDate25 May 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Elastomeric Pump
Model / Reference
485350N
Primary DI / UDI-DI
18859299121243
Basic UDI-DI
88592991B001U4
EMDN Code
A05010102 Elastomeric systems - fixed flow with additional bolus
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
TH-MF-000012102
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No