Milestones

13.06.2016
Establishment
23.12.2016
EN ISO 13485 Certificate

23.12.2016
7.04.2017
EC Certificate (93/42/EEC)
1.06.2017
Initial production of surgical drapes, gowns and packs

1.06.2017
1.11.2017
Export to 12 countries
8.04.2020
Renewal EC CERTIFICATE(93/42/EEC)-Notified Body: Kiwa

8.04.2020
20.08.2020
PPE Regulation-(EU) 2016/425 EU Type Examination Certificate-Protective Coverall Type 5-B,6-B
1.09.2020
TS EN 13795-1 Certificate

1.09.2020
2.11.2020
PPE Regulation-(EU) 2016/425 EU Type Examination Certificate-Isolation Gown Type PB(6)-B
18.12.2020
PPE Regulation-(EU) 2016/425 EU Type Examination Certificate-Protective Coverall Type 3-B,4-B

18.12.2020
20.01.2021
FDA Certificate of Registration(Initial)
10.02.2022
Machine installation for new product-underpad

10.02.2022
1.03.2022
Initial production of underpad
16.08.2023
FDA 510(k) Clearance of Sterile Triplex Surgical Gowns Regulation No: 21 CFR 878.4040

16.08.2023
26.09.2023
EAC Registration Certificate – Underpad, Adult Diapers, Adult Pants
26.10.2023
Currently exporting to 25 countries

26.10.2023
10.11.2023
Second Machine installation for underpad

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13.06.2016