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EUDAMED registration 04897128663479No

Gel Beads

INTCO MEDICAL (HK) CO., ltdClass IEU EUDAMEDTrade name: Compresse chaud/froid
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Z120602
Trade name
Compresse chaud/froid
Implantable
No
Reusable
Yes
Measuring function
No
Registration information
Primary DI
04897128663479
Basic UDI
489712866-0-GelBeadPL
Active status
No
Manufacturer
Manufacturer name
INTCO MEDICAL (HK) CO., ltd
Country
China
Country type
NON_EU
Address
301-307 FLAT/RM 19C, LOCKHART CENTRE, 301-307 LOCKHART ROAD HONG KONG
Email
andy@intco.com
Authorized representative
Name
MedNet EC-REP GmbH
SRN
DE-AR-000000002
Country
Germany
Address
10 Borkstrasse Münster
Email
ecrep@medneteurope.com
Telephone
+49 251 322 66 64
Regulatory information
Competent authority
DE/CA22 - Bezirksregierung Münster
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
France
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PHYSIOTHERAPY EQUIPMENT

About this record

Access comprehensive regulatory information for Gel Beads 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 04897128663479 and manufactured by INTCO MEDICAL (HK) CO., ltd in China.

This page provides complete registration details including trade name (Compresse chaud/froid), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Münster), 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.