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Manufacturer profile

Hartalega Sdn. Bhd.

EU EUDAMEDMalaysia6 registered devices
VerifiedEUDAMED · official EU database
6
Total devices
1
Risk classes
2021
Earliest version
2022
Latest version
Regulatory footprint
Search Hartalega Sdn. Bhd. across other regulatory registries
ThailandColombiaSouth KoreaCanadaEcuadorSaudi Arabia
Recent products (latest 6)
Most recently updated devices in the database
Nitrile Examination Gloves
04046955140589
Class I
Nitrile Examination Gloves
04046955140619
Class I
Nitrile Examination Gloves
04046955140640
Class I
Nitrile Examination Gloves
04046955140671
Class I
Nitrile Examination Gloves
04046955140701
Class I
Latex Powder Free Examination Gloves
09555244806105
Class I
Risk class distribution
Breakdown by risk classification
Class I6100.0% of total
Top authorized representatives
Most common authorized representatives for this manufacturer
Medical Device Safety Service GmbH (MDSS)
83.3%5 devices
MDSS GmbH
16.7%1 devices
About this profile

Explore comprehensive manufacturer profile for Hartalega Sdn. Bhd. through Pure Global AI's free EU medical device database. This company manufactures 6 medical devices registered with EUDAMED across 1 risk class based in Malaysia.

This page provides detailed insights including recent registrations, risk class distribution (Class I: 6), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.