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TransWarmer®

by CooperSurgical, Inc. United States EUDAMED

Ref 20421 EMDN Z12080407

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-20421EY Basic UDI-DIDate14 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
TransWarmer ®Infant Transport Mattress with WarmGel®
Model / Reference
20421
Primary DI / UDI-DI
D-20421EY
Basic UDI-DI
B-20421EY
EMDN Code
Z12080407 Neonatal radiant warmers
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000002607
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED D-20421EY|B-20421EY 61 fields · synced 25 Oct 2026