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Everest 2.0

by EnSafe sp.z o.o. EUDAMED

Active European Union

Ref K.E2.000Model EVACUATION CHAIR

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5906112206EnSafeChairAMC Basic UDI-DIDate1 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
EVACUATION CHAIR, K.E2.000
Primary DI / UDI-DI
05908015740858
Basic UDI-DI
5906112206EnSafeChairAMC
Direct Marketing DI
05908015740858
EMDN Code
Y99 Devices for persons with disabilities not included in other categories - other
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000042856

Other devices from EnSafe sp.z o.o.

See all devices from EnSafe sp.z o.o. →

Properties

Other properties (13)

  • Sterile: No
  • 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