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Hypothermia Blanket - EUDAMED Registration 05032483000883

Access comprehensive regulatory information for Hypothermia Blanket in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 05032483000883 and manufactured by Igloo Survival Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Igloo Survival Pro 3 Layer Hypothermia Blanket), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class I
05032483000883
No
Hypothermia Blanket
Trade Name: Igloo Survival Pro 3 Layer Hypothermia Blanket
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Device Description (EMDN)

HEATING COVERS - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T030399
Trade Name
Igloo Survival Pro 3 Layer Hypothermia Blanket
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05032483000883
Basic UDI
506013188IG-TF01UU
Version Date
December 20, 2024
Manufacturer Last Update
December 19, 2024
Active Status
No
Manufacturer
Manufacturer Name
Igloo Survival Limited
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Unit 26 Llandygai Industrial Estate Bangor, Gwynedd, Wales
Email
regulatory@igloosurvival.com
Authorized Representative
SRN
IE-AR-000003675
Country
Ireland
Address
Unit 17 Kylemore Road Dublin
Email
regulatory@reliancemedical.co.uk
Telephone
+44 8456 448808
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Ireland
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Tรผrkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No