Kossan International Sdn Bhd
Active in EUDAMEDMalaysiafrom SRN EUDAMED FDA SRN MY-MF-000022331 FEI 3009538921
- Devices
- 110
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
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 devicesDeviceDevice · Authorizations Verified Status Regime Registry Class
iNtouch Powder Free Ref INTW0560
Regimes: CE MDR Registry: EUDAMEDiNtouch Powder Free Ref INTW1065
Regimes: CE MDR Registry: EUDAMEDiNtouch Powder Free Ref INTW0570
Regimes: CE MDR Registry: EUDAMEDSterile Powder Free Nitrile Examination Gloves Ref K160467
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Showing 101-110 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
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 742058 Expiring
Quality assurance EU MDR
- Issued
- 23 Jan 2025
- Expires
- 10 Jan 2027
- Reason
- Mnf data change