EUDAMED registration 04897128662915NoRollator
INTCO MEDICAL (HK) CO., ltdClass IEU EUDAMEDTrade name: Rollator
VerifiedEUDAMED · official EU database
Device classification
- Risk class
- Class I
- CND nomenclatures code
- Y120606
- Trade name
- Rollator
- Implantable
- No
- Reusable
- No
- Measuring function
- No
Registration information
- Primary DI
- 04897128662915
- Basic UDI
- 489712866-0-RollatorE4
- Version date
- December 02, 2023
- Manufacturer last update
- August 09, 2021
- 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
- andy@intco.com
Authorized representative
- SRN
- DE-AR-000000002
- Country
- Germany
- Address
- 10 Borkstrasse Münster
- 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
- Germany
Device characteristics
- Human tissues
- No
- Animal tissues
- No
Device description (EMDN)
WHEELED WALKER
About this record
Access comprehensive regulatory information for Rollator 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 04897128662915 and manufactured by INTCO MEDICAL (HK) CO., ltd in China.
This page provides complete registration details including trade name (Rollator), 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.