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Pentavest Holdings Sdn Bhd

Active in EUDAMED

Malaysiafrom SRN EUDAMED FDA SRN MY-MF-000011697 FEI 3021915797

Devices
15
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
MedNet EC-REP GmbHDE

Catalogue15

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Company details

EUDAMED SRN
MY-MF-000011697
FDA FEI number
3021915797
EUDAMED status
Active
EUDAMED registered name
PENTAVEST HOLDINGS SDN BHD
Registered address
No. 9574-9578,, Jalan PTB 2,, 76400, MELAKA, Malaysia
Phone
6063516899(from company website)
PRRC contact
MICHELL ONG JIAN HUI(public in EUDAMED)

From the company website

Read 18 Sep 2026

Pentavest Holdings Sdn Bhd is a Malaysian-based gloves manufacturer specializing in the production of industrial-grade and medical-grade synthetic gloves. With over 35 years of experience in capital equipment for rubber product manufacturing, Pentavest has been involved in rubber glove production since 1985. The company manufactures disposable synthetic and latex gloves for both industrial and medical industries. Led by Datuk Teng, who has extensive experience in the rubber industry, Pentavest supplies state-of-the-art manufacturing equipment to its affiliate manufacturers. To meet the growing global demand in the glove industry, Pentavest has established a modern manufacturing plant spanning 16.2 square kilometers in Malacca. The facility has the capacity to produce approximately 178 million gloves annually per production line. Pentavest has a long-term expansion plan to increase its manufacturing capacity by adding 30 production lines by 2026, aiming to become a reputable global glove sourcing center.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does PENTAVEST HOLDINGS SDN BHD have in the registry?

The registry currently lists 15 devices for PENTAVEST HOLDINGS SDN BHD. Devices recorded under merged duplicate company entries are counted once.

Which registries list PENTAVEST HOLDINGS SDN BHD's devices?

Among its 15 most recently registered devices, PENTAVEST HOLDINGS SDN BHD has devices listed in EUDAMED (13 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do PENTAVEST HOLDINGS SDN BHD's devices fall under?

Among its 15 most recently registered devices, the classes recorded for PENTAVEST HOLDINGS SDN BHD's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from PENTAVEST HOLDINGS SDN BHD in the registry?

The most recently registered devices listed for PENTAVEST HOLDINGS SDN BHD include PENTANANO ANTIMICROBIAL NITRILE EXAMINATION GLOVES, Penta Glove and Sterile Latex Surgical Gloves Powder Free.

Generated automatically from registry data and not verified by a human reviewer.