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Wellet

by ab medica spa EUDAMED

Active European Union

Ref ABWEL-SWEL001

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++E296ABWELSYS74 Basic UDI-DIDate13 Oct 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  • Withdrawn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

Model / Reference
ABWEL-SWEL001
Primary DI / UDI-DI
E296ABWELSWEL0010
Basic UDI-DI
++E296ABWELSYS74
EMDN Code
Z1203020601 Complete vital signs telemetry systems
Device Class
Class IIa
Medical Purpose
Wellet system is intended to monitor physiological parameters (blood pressure, pulse oximetry, 7- or 12-lead ECG, heart rate, respiratory rate, body temperature, and posture).

Manufacturer details

EUDAMED SRN
IT-PR-000029708

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Properties

Other properties (1)

  • Sterile: No