Kossan International Sdn Bhd
Active in EUDAMEDMalaysiafrom SRN EUDAMED FDA SRN MY-MF-000022331 FEI 3009538921
- Devices
- 110
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Kossan International Sdn Bhd makes
Kossan International Sdn Bhd manufactures powder-free latex and nitrile patient examination gloves in various colors, including black, pink, orange, and blue. Some nitrile gloves are specifically tested for use with chemotherapy drugs and fentanyl citrate, and certain variants are labeled for low dermatitis potential or include protein content claims.
The company's devices are classified as Class I medical devices and are listed in the FDA 510(k) registry. Kossan International Sdn Bhd is based in the United States.
Catalogue
Search and filter all 110 devicesShowing 1-50 of 110
Company details
- EUDAMED SRN
- MY-MF-000022331
- FDA FEI number
- 3009538921
- EUDAMED status
- Active
- EUDAMED registered name
- Kossan International Sdn Bhd
- EUDAMED abbreviated name
- KISB
- Registered address
- KOSSAN Tower No. 6D, Persiaran Setia Dagang, Setia Alam, Seksyen U13,, 40170, Shah Alam, Malaysia
- [email protected]
- PRRC contact
- CHO SOW FONG
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 10 Jan 2027
Notified body 2797 1 certificate
- MDR 742058 Amended
Quality assurance EU MDR
- Issued
- 23 Jan 2025
- Expires
- 10 Jan 2027
- Reason
- Mnf data change
Frequently asked questions
How many devices does Kossan International Sdn Bhd have in the registry?
The registry currently lists 110 devices for Kossan International Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kossan International Sdn Bhd's devices?
Among its 50 most recently registered devices, Kossan International Sdn Bhd has devices listed in EUDAMED (44 devices) and FDA 510(k) (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Kossan International Sdn Bhd's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Kossan International Sdn Bhd's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Kossan International Sdn Bhd?
EUDAMED lists 1 certificate for Kossan International Sdn Bhd (quality assurance) under MDR. The most recent was issued on 2025-01-23.
What are the newest devices from Kossan International Sdn Bhd in the registry?
The most recently registered devices listed for Kossan International Sdn Bhd include iNtouch Powder Free, iNtouch Nitrile LD Derma-care, iNtouch Nitrile Shield-aid and soft-hand NITRIL.