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Opera® Impulse Powered Hybrid Mattress

by Alpine HC t/a Opera® United Kingdom EUDAMED

Ref MAM021-40 EMDN V080701

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5060665480116WR Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Opera® Impulse Powered Hybrid Mattress
Model / Reference
MAM021-40
Primary DI / UDI-DI
50606654806668, 05060665480666
Basic UDI-DI
5060665480116WR
Direct Marketing DI
50606654806668
05060665480666
EMDN Code
V080701 Active anti-decubitus medical mattresses
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000033029
Authorised representative
Rubicon Technical Limited NL-AR-000006630

From the manufacturer

Manufacturer's product page: Pressure Care Mattresses Static, dynamic and hybrid pressure surfaces designed to prevent and treat bed sores.

Other devices from Alpine HC t/a Opera®

See all devices from Alpine HC t/a Opera® →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 487eeec4-8bce-47b9-be42-3aa0735bdb82 61 fields · synced 24 Oct 2026
  • EUDAMED 05060665480666|5060665480116WR 61 fields · synced 18 Jun 2026