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Eos

by North Eos Industries, Inc. Taiwan EUDAMED

Ref EosSpec IV-DILATOR 9-10/MM-STERILEModel EosSpec

EMDN U089006

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471256836SGYNJ8 Basic UDI-DIDate3 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
EosSpec, EosSpec IV-DILATOR 9-10/MM-STERILE
Primary DI / UDI-DI
04712568361177
Basic UDI-DI
471256836SGYNJ8
Direct Marketing DI
04712568361177
EMDN Code
U089006 Vaginal speculum, single-use
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
TW-MF-000007743
Authorised representative
Advena Limited MT-AR-000000234

Other devices from North Eos Industries, Inc.

See all devices from North Eos Industries, Inc. →

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 04712568361177|471256836SGYNJ8 61 fields · synced 24 Oct 2026