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EUDAMED registration 09555839948043No

Sterile Latex Surgical Powder Free Glove

TG MEDICAL SDN. BHD.Class IIaEU EUDAMEDTrade name: Top Glove
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
T01010102
Trade name
Top Glove
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
09555839948043
Basic UDI
955583990800Q3
Version date
February 27, 2025
Manufacturer last update
July 13, 2021
Active status
No
Manufacturer
Manufacturer name
TG MEDICAL SDN. BHD.
Country
Malaysia
Country type
NON_EU
Address
LOT 5091 JALAN TERATAI, BATU 5, OFF JALAN MERU 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
Market available
Germany:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

NON-POWDERED LATEX SURGICAL GLOVES

About this record

Access comprehensive regulatory information for Sterile Latex Surgical Powder Free Glove in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 09555839948043 and manufactured by TG MEDICAL SDN. BHD. in Malaysia.

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