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Carilex

by Carilex Medical, Inc United States EUDAMED

Ref S2202-2210Model TheraFlo AP

EMDN V080701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987369S2XXXS4 Basic UDI-DIDate4 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Anti-decubitus Air Alternating Pressure Device and System with Accessories
Model / Reference
TheraFlo AP, S2202-2210
Primary DI / UDI-DI
04719873693504
Basic UDI-DI
471987369S2XXXS4
Direct Marketing DI
04719873693504
EMDN Code
V080701 Active anti-decubitus medical mattresses
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000002145
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Carilex Medical, Inc.

See all devices from Carilex Medical, Inc. →

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 (1)

  • EUDAMED 05185136-abba-4b3c-86cf-e73a847a08a6 61 fields · synced 22 Oct 2026