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Hot or Cold packs - EUDAMED Registration 05060738578719

Access comprehensive regulatory information for Hot or Cold packs 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 05060738578719 and manufactured by Reliance Medical Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Baby Shark Hot/Cold Pack), 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
05060738578719
Yes
Hot or Cold packs
Trade Name: Baby Shark Hot/Cold Pack
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Device Description (EMDN)

VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V9099
Trade Name
Baby Shark Hot/Cold Pack
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060738578719
Basic UDI
506013188TF263U
Version Date
February 06, 2025
Manufacturer Last Update
September 12, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
Reliance Medical Ltd
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
West Avenue Stoke on Trent
Email
regulatory@reliancemedical.co.uk
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, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No