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SMARTeZ RS-Chemo 270-2-135h

by Epic International (Thailand) Co., Ltd.

Ref 475180

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number18859299175185 UDI-DI Date4 Sep 2026ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number88592991B001U4 Basic UDI-DI 18859299175185UDI-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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SMARTeZ RS-Chemo 270-2-135h EUDAMED
SMARTeZ RS GUDID
Generic Name
Elastomeric infusion pump system
Device Name
Elastomeric Pump
Model / Reference
475180
Primary DI / UDI-DI
18859299175185
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
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Related devices

Category: Elastomeric infusion pump system

Other devices from Epic International (Thailand) Co., Ltd.

See all devices from Epic International (Thailand) Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No