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Insulin Syringe

by Multigate Co., Ltd China EUDAMED

Ref IV122127Model 0.3ml、0.5ml、1ml

EMDN A02010602

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697201396MU2ASNNNSIS002PS Basic UDI-DIDate27 Aug 2025RegisteredStatusActive

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
0.3ml、0.5ml、1ml, IV122127
Primary DI / UDI-DI
09341601005683
Basic UDI-DI
697201396MU2ASNNNSIS002PS
EMDN Code
A02010602 Insulin syringes w/o fixed needles, single-use
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000002513
Authorised representative
RFX+Care International A/S DK-AR-000001768

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 74c9a306-0a4c-4ee9-8843-4051fe4c2aa9 61 fields · synced 22 Oct 2026