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Kit Accessories Sphera

by Edif Instruments S.r.l. Italy EUDAMED

Ref ACC07101A-001A, ACC07100Model Kit Accessories EMDN W0201010180,W0201020180

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805360894ACC0710067 Basic UDI-DIDate25 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Kit Accessories Sphera
Kit Accessories
Model / Reference
Kit Accessories, ACC07101A-001A, ACC07100
Primary DI / UDI-DI
80536089417102, 80536089418338
Basic UDI-DI
805360894ACC0710067
Direct Marketing DI
80536089417102
80536089418338
EMDN Code
W0201010180,W0201020180
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009556

Other devices from Edif Instruments S.r.l.

See all devices from Edif Instruments S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED b1013a3a-2d6e-444d-a88c-98051382c7f5 61 fields · synced 22 Oct 2026
  • EUDAMED 80536089418338|805360894ACC0710067 61 fields · synced 19 May 2026