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EUDAMED registration 04897128663219No

manual wheelchair

INTCO MEDICAL (HK) CO., ltdClass IEU EUDAMEDTrade name: YK9031
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Y122106
Trade name
YK9031
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
04897128663219
Basic UDI
489712866-0-MWheelchairX2
Version date
May 30, 2024
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
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
Germany
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

REAR SELF-PROPELLED WHEELCHAIRS

About this record

Access comprehensive regulatory information for manual wheelchair 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 04897128663219 and manufactured by INTCO MEDICAL (HK) CO., ltd in China.

This page provides complete registration details including trade name (YK9031 ), 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.