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Needle Free Injection System (N-FIS)

by IntegriMedical Private Limited India EUDAMED

Ref CENFIS001

EMDN A99

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890613015CENFIS0012C Basic UDI-DIDate15 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CENFIS001
Primary DI / UDI-DI
08906130150085, 28906130150089
Basic UDI-DI
890613015CENFIS0012C
EMDN Code
A99 Devices for administration, withdrawal and collection - other
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
IN-MF-000026571
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from IntegriMedical Private Limited

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 1966ad0f-9c2c-4267-9fcf-1aeb292f2a21 61 fields · synced 22 Oct 2026
  • EUDAMED 61b1251c-dc16-4653-98c9-fd25d8379944 61 fields · synced 19 May 2026