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EUDAMED registration 06221329007790No

Thermoregulating hydrogel

PharmaplastClass IEU EUDAMEDTrade name: Fevogel
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
M9001
Trade name
Fevogel
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06221329007790
Basic UDI
62220238Fevocool8P
Version date
July 29, 2024
Manufacturer last update
June 29, 2024
Active status
No
Manufacturer
Manufacturer name
Pharmaplast
Country
Egypt
Country type
NON_EU
Address
Amria free zone Alexandria
Email
ra@pharmaplast-online.com
Authorized representative
Name
E C REP LIMITED
SRN
IE-AR-000003995
Country
Ireland
Address
5 Fitzwilliam Square East Dublin D2
Email
info@ecrep.ie
Telephone
+353 89 225 1951
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
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CRYOTHERAPY AND THERMOTHERAPY DEVICES

About this record

Access comprehensive regulatory information for Thermoregulating hydrogel 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 06221329007790 and manufactured by Pharmaplast in Egypt.

This page provides complete registration details including trade name (Fevogel), 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.