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ANNE Limb Adhesive

by Sibel Health Inc. EUDAMED

Active European Union

Ref 900-00071Model SA-004-01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08500642100JG Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
ANNE One System
Model / Reference
SA-004-01, 900-00071
Primary DI / UDI-DI
00850064210293
Basic UDI-DI
08500642100JG
EMDN Code
Z1203020285 Multi-parameter monitors - consumables
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000037280
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Sibel Health Inc.

See all devices from Sibel Health Inc. →

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