PALAPALA KAKAU KAUKAU

ʻO TEKNA Hana Pvt. Ltd.

C-19, Waiwai Hana, Guindy Chennai, Tamil Nadu 600032 INDIA

Hoʻopuka nā lawelawe lawelawe lāʻau lapaʻau UL o UL LLC® (UL) i kēia palapala hōʻoia i ka Firm i ʻōlelo ʻia ma luna, ma hope o ka hōʻoia ʻana i ka ʻōnaehana hoʻokele maikaʻi o ka Firm a loaʻa iā ia e like me ka palena i ho'ākāka ʻia e pili ana i:

ISO 13485: 2016

me nā koi hoʻokele hou i helu ʻia ma ka ʻaoʻao hope o kēia palapala. ʻO ka hoʻolālā, hana, lawelawe a me ke kau ʻana o nā keʻena hyperbaric.

Ua ʻae ʻia e

ʻO Michael J. Windler, PE Luna o ka Global Regulate Service Distinguished Member of the Technical Staff UL Life and Health Science
UL LLC

Hōʻoia palapala

Kūlana: ma aneʻi

Nā Pono Hana REP:

Helu Helu Palapala Helu Helu Kuhi Ka lā mua

A28843 3017.200413 ʻApelila 13, 2020

ʻO ka lā hoʻomaka o ka pōʻaiapuni ʻO ka lā palena pau

ʻApelila 13, 2020 ʻApelila 13, 2020 ʻApelila 12, 2023

Hoʻokomo ʻia kēia ʻōnaehana hoʻopaʻa inoa maikaʻi i loko o ka Papa Kuhikuhi o UL o nā ʻoihana i hoʻopaʻa ʻia a pili i ka hoʻolako ʻana i nā waiwai a me / a i ʻole nā ​​lawelawe e like me ka mea i hōʻike ʻia i ka laulā o ke kau inoa ʻana mai ka helu wahi (es) i hōʻike ʻia ma luna. Ma ka hoʻopuka ʻana o kēia palapala hōʻike ka firm i kahi e mālama ia i kāna hoʻopaʻa inoa e like me nā koi e pili ana. ʻAʻole hiki ke hoʻolilo ʻia kēia palapala hōʻoia a lilo ia i waiwai no UL Medical and Regulate Services o UL LLC.

E hōʻoia ʻia nā palapala hōʻoia e ke kipa ʻana i ka Papa Kuhikuhi Pūnaewele Pūnaewele ma UL.com.

Hoʻopuka 00-MB-F0867 1.0 ʻAoʻao 1 o 2

UL Lapaʻau a me nā lawelawe lawelawe UL, LLC kahi MDSAP e ʻike ʻia ka hui hōʻoia hōʻoia

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

ʻO UL a me ka logo UL nā inoa inoa o Underwriters Laboratories Inc. © 2011.

PALAPALA KAKAU KAUKAU

ʻO TEKNA Hana Pvt. Ltd.

C-19, Waiwai Hana, Guindy Chennai, Tamil Nadu 600032 INDIA

Nā Koina Hoʻonohonoho Hou

Nā Pono Hana REP:

Nuhōlani:
- Nā Rula Therapyutic Goods (Medical Devices), 2002, Papa Kuhikuhi 3 ʻĀpana 1 (me ka hoʻokaʻawale ʻole i ka ʻāpana 1.6)

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

Kanada:
- Nā Rula Hoʻolaha Lapaʻau - Mahele 1- SOR 98/282

Iapana:
- MHLW Kuhina Kuhina 169, ʻatikala 4 a i ka ʻatikala 68 - Kānāwai PMD (, e pili ana)

ʻAmelika Hui Pū ʻIa:

• - 21 CFR 820

• - 21 CFR 803

• - 21 CFR 806

  - 21 CFR 807 - Nā ʻāpana A a D

- 21 CFR 821 (kahi e pili ai)

Helu Helu Palapala Helu Helu Kuhi Ka lā mua

A28843 3017.200413 ʻApelila 13, 2020

ʻO ka lā hoʻomaka o ka pōʻaiapuni ʻO ka lā palena pau

ʻApelila 13, 2020 ʻApelila 13, 2020 ʻApelila 12, 2023

Hoʻokomo ʻia kēia ʻōnaehana hoʻopaʻa inoa maikaʻi i loko o ka Papa Kuhikuhi o UL o nā ʻoihana i hoʻopaʻa ʻia a pili i ka hoʻolako ʻana i nā waiwai a me / a i ʻole nā ​​lawelawe e like me ka mea i hōʻike ʻia i ka laulā o ke kau inoa ʻana mai ka helu wahi (es) i hōʻike ʻia ma luna. Ma ka hoʻopuka ʻana o kēia palapala hōʻike ka firm i kahi e mālama ia i kāna hoʻopaʻa inoa e like me nā koi e pili ana. ʻAʻole hiki ke hoʻolilo ʻia kēia palapala hōʻoia a lilo ia i waiwai no UL Medical and Regulate Services o UL LLC.

E hōʻoia ʻia nā palapala hōʻoia e ke kipa ʻana i ka Papa Kuhikuhi Pūnaewele Pūnaewele ma UL.com.

Hoʻopuka 00-MB-F0867 1.0 ʻAoʻao 2 o 2

UL Lapaʻau a me nā lawelawe lawelawe UL, LLC kahi MDSAP e ʻike ʻia ka hui hōʻoia hōʻoia

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

ʻO UL a me ka logo UL nā inoa inoa o Underwriters Laboratories Inc. © 2011.