SETEREKE SA HO NGOLISA

TEKNA Tlhahiso ea Pvt. Ltd.

C-19, Ntlo ea Liindasteri, Guindy Chennai, Tamil Nadu 600032 INDIA

Litšebeletso tsa Tsamaiso ea Bongaka ea UL ea UL LLC® (UL) e fana ka setifikeiti sena ho Firm e boletsoeng kaholimo, kamora ho hlahloba tsamaiso ea Firm ea taolo ea boleng le ho e fumana e le tumellanong le boholo bo hlalositsoeng mabapi le:

ISO 13485: 2016

ka litlhoko tse ling tsa taolo tse thathamisitsoeng leqepheng la ho qetela la setifikeiti sena. Moralo, tlhahiso, ts'ebeletso le ho kenya likamore tsa hyperbaric.

E lumelletsoe ke

Michael J. Windler, Motsamaisi oa PE oa Ts'ebetso ea Tsamaiso ea Global Global Setho se Ikhethileng sa Basebetsi ba Tekheniki UL Bophelo le Saense ea Bophelo
UL LLC

Lekola Setifikeiti

Boemo: mona

ID ea Setsi sa REP:

Nomoro ea Setifikeiti sa Nomoro ea Faele Letsatsi la Pele

A28843 3017.200413 Mmesa 13, 2020

Letsatsi la ho qala ha potoloho Letsatsi le sebetsang la ho felloa ke nako Letsatsi

Mmesa 13, 2020 Mmesa 13, 2020 Mmesa 12, 2023

Ngoliso ena ea sistimi ea boleng e kenyelelitsoe bukaneng ea lifeme tse ngolisitsoeng tsa UL mme e sebetsa ho phano ea thepa le / kapa lits'ebeletso joalo ka ha ho boletsoe boemong ba ngoliso ho tsoa atereseng e bontšitsoeng kaholimo. Ka ho fana ka setifikeiti sena feme e emela hore e tla boloka ngoliso ea eona ho latela litlhoko tse hlokahalang. Setifikeiti sena ha se fetisoe ebile se lula e le thepa ea UL Medical and Regulatory Services ea UL LLC.

Litifikeiti li ka netefatsoa ka ho etela Directory ea Certification ea inthaneteng ho UL.com.

00-MB-F0867 Phatlalatso ea 1.0 Leqephe la 1 la 2

Litšebeletso tsa Bongaka le tsa Taolo ea UL, LLC ke MDSAP Recognised Auditing Organisation

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

UL le logo ea UL ke matšoao a khoebo a Underwriters Laboratories Inc. © 2011.

SETEREKE SA HO NGOLISA

TEKNA Tlhahiso ea Pvt. Ltd.

C-19, Ntlo ea Liindasteri, Guindy Chennai, Tamil Nadu 600032 INDIA

Litlhoko tse ling tsa taolo

ID ea Setsi sa REP:

Australia:
- Melao ea Thepa ea Phekolo (Lisebelisoa tsa Bongaka), 2002, Shejulu 3 Karolo ea 1 (ntle le Karolo ea 1.6) - Tsamaiso e felletseng ea Netefatso ea Boleng

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

Canada:
- Melao ea lisebelisoa tsa bongaka - Karolo ea 1- SOR 98/282

Japane:
- MHLW Ministerial Ordinance 169, Article 4 ho Article 68 - PMD Act (, ha ho hlokahala)

United States:

• - 21 CFR 820

• - 21 CFR 803

• - 21 CFR 806

  - 21 CFR 807 - E arola A ho ea ho D

- 21 CFR 821 (moo ho hlokahalang)

Nomoro ea Setifikeiti sa Nomoro ea Faele Letsatsi la Pele

A28843 3017.200413 Mmesa 13, 2020

Letsatsi la ho qala ha potoloho Letsatsi le sebetsang la ho felloa ke nako Letsatsi

Mmesa 13, 2020 Mmesa 13, 2020 Mmesa 12, 2023

Ngoliso ena ea sistimi ea boleng e kenyelelitsoe bukaneng ea lifeme tse ngolisitsoeng tsa UL mme e sebetsa ho phano ea thepa le / kapa lits'ebeletso joalo ka ha ho boletsoe boemong ba ngoliso ho tsoa atereseng e bontšitsoeng kaholimo. Ka ho fana ka setifikeiti sena feme e emela hore e tla boloka ngoliso ea eona ho latela litlhoko tse hlokahalang. Setifikeiti sena ha se fetisoe ebile se lula e le thepa ea UL Medical and Regulatory Services ea UL LLC.

Litifikeiti li ka netefatsoa ka ho etela Directory ea Certification ea inthaneteng ho UL.com.

00-MB-F0867 Phatlalatso ea 1.0 Leqephe la 2 la 2

Litšebeletso tsa Bongaka le tsa Taolo ea UL, LLC ke MDSAP Recognised Auditing Organisation

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

UL le logo ea UL ke matšoao a khoebo a Underwriters Laboratories Inc. © 2011.