Hartalega Sdn Bhd
Active in EUDAMEDMalaysiafrom SRN EUDAMED FDA SRN MY-MF-000010461 FEI 3002807146
- Devices
- 63
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- MDSS GmbHDE
Catalogue
Search and filter all 63 devicesShowing 1-50 of 63
Company details
- EUDAMED SRN
- MY-MF-000010461
- FDA FEI number
- 3002807146
- EUDAMED status
- Active
- EUDAMED registered name
- Hartalega Sdn. Bhd.
- Registered address
- C-G-9, Jalan Dataran SD1, 52200, Kuala Lumpur, Malaysia
- Website
- hartalega.com.my/
- [email protected]
- Phone
- +603-6277 1733
- PRRC contact
- Nurul Aisyah Kong Abdullah
Frequently asked questions
How many devices does Hartalega Sdn Bhd have in the registry?
The registry currently lists 63 devices for Hartalega Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hartalega Sdn Bhd's devices?
Among its 50 most recently registered devices, Hartalega Sdn Bhd has devices listed in EUDAMED (3 devices) and FDA 510(k) (47 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hartalega Sdn Bhd's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Hartalega Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hartalega Sdn Bhd in the registry?
The most recently registered devices listed for Hartalega Sdn Bhd include Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue), Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs and LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M.