Pure Global
09551004343750

Nitrile Examination Powder Free Gloves

TOP GLOVE SDN. BHD.·Class I·EU EUDAMED·Trade name: Screen Touch Nitril PurpleNo
Device classification
Risk class
Class I
CND nomenclatures code
T01020204
Trade name
Screen Touch Nitril Purple
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
09551004343750
Basic UDI
955760101940H5
Version date
September 13, 2024
Manufacturer last update
July 14, 2021
Active status
No
Manufacturer
Manufacturer name
TOP GLOVE SDN. BHD.
Country
Malaysia
Country type
NON_EU
Address
LOT 4969 JALAN TERATAI BATU 6, OFF JALAN MERU, 41050 KLANG, SELANGOR DARUL EHSAN, MALAYSIA. KLANG
Email
poststelle@bezreg-duesseldorf.nrw.de
Authorized representative
Name
Top Glove Europe GmbH
SRN
DE-AR-000004968
Country
Germany
Address
80 a Bliersheimer Str. Duisburg
Email
info@topglove.de
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
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)

NITRILE EXAMINATION / TREATMENT GLOVES

About this record

Access comprehensive regulatory information for Nitrile Examination Powder Free Gloves 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 09551004343750 and manufactured by TOP GLOVE SDN. BHD. in Malaysia.

This page provides complete registration details including trade name (Screen Touch Nitril Purple), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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.