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Igloo Survival Pro 3 Layer Hypothermia Blanket

by Igloo Survival Limited 3 variants

Ref IG004

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506013188IG-TF01UU Basic UDI-DI 05032483000890UDI-DIDate20 Dec 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Hypothermia Blanket
Model / Reference
IG004
Primary DI / UDI-DI
05032483000890
Basic UDI-DI
506013188IG-TF01UU
EMDN Code
T030399 Heating covers - other
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000045647
Authorised representative
Reliance Medical (Ireland) IE-AR-000003675

Other devices from Igloo Survival Limited

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