ISITifikethi SOKUBHALISA

TEKNA Ukukhiqiza Pvt. Ltd.

C-19, Industrial Estate, eGuindy Chennai, eTamil Nadu 600032 INDIA

I-UL Medical Regulatory Services ye-UL LLC® (UL) ikhipha lesi sitifiketi kuFirm eshiwo ngenhla, ngemuva kokucwaninga uhlelo lokuphathwa kwekhwalithi yeFirm nokuyithola ngokuhambisana nobubanzi obuchaziwe maqondana ne:

ISO 13485: 2016

nezidingo ezingeziwe zokulawula ezisohlwini lokugcina lwalesi sitifiketi. Ukwakhiwa, ukwenziwa, insizakalo kanye nokufakwa kwamagumbi we-hyperbaric.

Igunyazwe ngu-

UMichael J. Windler, Umphathi we-PE weGlobal Regulatory Service iLungu eliKhethekile leTechnical Staff UL Life and Health Sciences
I-UL LLC

Hlola Isitifiketi

Isimo: lapha

I-ID yendawo ye-REPs:

Usuku Lokukhishwa Kwenombolo Yesitifiketi Senombolo Yefayela

A28843 3017.200413 Ephreli 13, 2020

Usuku Lokuqala Lomjikelezo Usuku Lokuphela Kosuku Ukuphela Kwalo

Ephreli 13, 2020 Ephreli 13, 2020 Ephreli 12, 2023

Lokhu kubhaliswa kohlelo lwekhwalithi kufakiwe kuhla lwemibhalo lwamafemu abhalisiwe e-UL futhi kusebenza ekuhlinzekweni kwezimpahla kanye / noma izinsizakalo njengoba kucacisiwe kububanzi bokubhalisa kusuka kukheli eliboniswe ngenhla. Ngokukhishwa kwalesi sitifiketi ifemu imele ukuthi izogcina ukubhaliswa kwayo ngokuya ngezidingo ezisebenzayo. Lesi sitifiketi asidluliseki futhi sihlala siyimpahla ye-UL Medical and Regulatory Services ye-UL LLC.

Izitifiketi zingaqinisekiswa ngokuvakashela Uhla lwemibhalo Yezitifiketi Eziku-inthanethi ku-LU.com.

00-MB-F0867 Ukukhishwa kwe-1.0 Ikhasi 1 kwe-2

Izinsizakalo ze-UL Medical and Regulatory Services UL, LLC yi-MDSAP Recognised Auditing Organization

I-UL LLC 333 Pfingsten Road Northbrook, IL 60062-2096 USA

I-UL kanye nelogo ye-UL yizimpawu zokuhweba ze-Underwriters Laboratories Inc. © 2011.

ISITifikethi SOKUBHALISA

TEKNA Ukukhiqiza Pvt. Ltd.

C-19, Industrial Estate, eGuindy Chennai, eTamil Nadu 600032 INDIA

Izidingo Ezengeziwe Zokulawulwa

I-ID yendawo ye-REPs:

I-Australia:
- Imithethonqubo Yezimpahla Zokwelapha

I-Brazil:
- RDC ANVISA n. 16/2013 - RDC ANVISA n. 23/2012 - RDC ANVISA n. 67/2009

I-Canada:
- Imithethonqubo Yamadivayisi Wezokwelapha - Ingxenye 1- SOR 98/282

I-Japan:
- I-MHLW Ministerial Ordinance 169, Article 4 kuya ku-Article 68 - PMD Act (, njengoba kusebenza)

I-united states:

• - 21 CFR 820

• - 21 CFR 803

• - 21 CFR 806

  - 21 CFR 807 - Ifaka A kuya kuD

- 21 CFR 821 (lapho kufanele khona)

Usuku Lokukhishwa Kwenombolo Yesitifiketi Senombolo Yefayela

A28843 3017.200413 Ephreli 13, 2020

Usuku Lokuqala Lomjikelezo Usuku Lokuphela Kosuku Ukuphela Kwalo

Ephreli 13, 2020 Ephreli 13, 2020 Ephreli 12, 2023

Lokhu kubhaliswa kohlelo lwekhwalithi kufakiwe kuhla lwemibhalo lwamafemu abhalisiwe e-UL futhi kusebenza ekuhlinzekweni kwezimpahla kanye / noma izinsizakalo njengoba kucacisiwe kububanzi bokubhalisa kusuka kukheli eliboniswe ngenhla. Ngokukhishwa kwalesi sitifiketi ifemu imele ukuthi izogcina ukubhaliswa kwayo ngokuya ngezidingo ezisebenzayo. Lesi sitifiketi asidluliseki futhi sihlala siyimpahla ye-UL Medical and Regulatory Services ye-UL LLC.

Izitifiketi zingaqinisekiswa ngokuvakashela Uhla lwemibhalo Yezitifiketi Eziku-inthanethi ku-LU.com.

00-MB-F0867 Ukukhishwa kwe-1.0 Ikhasi 2 kwe-2

Izinsizakalo ze-UL Medical and Regulatory Services UL, LLC yi-MDSAP Recognised Auditing Organization

I-UL LLC 333 Pfingsten Road Northbrook, IL 60062-2096 USA

I-UL kanye nelogo ye-UL yizimpawu zokuhweba ze-Underwriters Laboratories Inc. © 2011.