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Infusion Set for Single Use (Vented) Standards

by SBRG MedTech Pvt. Ltd. EUDAMED

Active European Union

Ref 01020101Model Infusion Set for Single Use

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89061712501025E Basic UDI-DIDate23 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

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.

Specification

EUDAMED

Device Name
Infusion Set for Single Use
Model / Reference
Infusion Set for Single Use, 01020101
Primary DI / UDI-DI
08906171250508
Basic UDI-DI
89061712501025E
EMDN Code
A03010101 Infusion controllers with or w/o air inlet
Device Class
Class IIa
Market of Registration
Estonia

Manufacturer details

EUDAMED SRN
IN-MF-000038015
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from SBRG MedTech Pvt. Ltd.

See all devices from SBRG MedTech Pvt. Ltd. →

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