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EUDAMED registration 09555244806105No

Latex Powder Free Examination Gloves

Hartalega Sdn. Bhd.Class IEU EUDAMEDTrade name: Top Dent Latex 5.0G
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
T010201
Trade name
Top Dent Latex 5.0G
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
09555244806105
Basic UDI
955524480HSBTFMD001A57
Version date
November 02, 2021
Manufacturer last update
July 23, 2021
Active status
No
Manufacturer
Manufacturer name
Hartalega Sdn. Bhd.
Country
Malaysia
Country type
NON_EU
Address
C-G-9, Jalan Dataran SD1 Kuala Lumpur
Email
wkkong@hartalega.com.my
Authorized representative
Name
MDSS GmbH
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory information
Competent authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Denmark
Market available
Denmark:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

LATEX EXAMINATION / TREATMENT GLOVES

About this record

Access comprehensive regulatory information for Latex Powder Free Examination 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 09555244806105 and manufactured by Hartalega Sdn. Bhd. in Malaysia.

This page provides complete registration details including trade name (Top Dent Latex 5.0G), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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.