CERTIFICATE YOKUNyoresa

TEKNA Kugadzira Pvt. Ltd.

C-19, Industrial Estate, Guindy Chennai, Tamil Nadu 600032 INDIA

UL Medical Regulatory Services ye UL LLC® (UL) inopa chitupa ichi kuFirm yakadudzwa pamusoro apa, mushure mekuongorora Firm's mhando manejimendi manejimendi uye nekuiwana ichienderana neyakaenzana chiyero maererano ne:

ISO 13485: 2016

iine zvekuwedzera zvinodiwa zvemutemo zvakanyorwa pane yekupedzisira peji reichi chitupa. Dhizaini, kugadzira, sevhisi uye kumisikidzwa kwemakamuri e hyperbaric.

Mvumo na

Michael J. Windler, PE Maneja weGlobal Regulatory Service Inosarudzika Nhengo yeTechnical Staff UL Hupenyu uye Hutano Sayenzi
UL LLC

Tarisa Chitupa

Mamiriro: apa

REPs Nzvimbo ID:

Faira Nhamba Chitupa Nhamba Yekutanga Nyaya Yakaburitswa Zuva

A28843 3017.200413 Kubvumbi 13, 2020

Kutenderera Kwokutanga Zuva Rinoshanda Zuva Rokupera Zuva

Kubvumbi 13, 2020 Kubvumbi 13, 2020 Kubvumbi 12, 2023

Iyi yehunhu system kunyoreswa inosanganisirwa muLL Directory yeVanyoresa maFemu uye inoshanda kune kupihwa kwezvinhu uye / kana masevhisi sezvakatsanangurwa muchiyero chekunyoresa kubva kukero (es) inoratidzwa pamusoro. Nekuburitswa kweichi chitupa iyo firm inomiririra kuti ichachengetedza kunyoreswa kwayo zvinoenderana nezvinodiwa. Chitupa ichi hachichinjwe uye chinoramba chiri chivakwa cheUL Medical uye Regulatory Services yeL LLC.

Zvitifiketi zvinogona kusimbiswa nekushanyira iyo Online Certification Dhairekitori pane UL.com.

00-MB-F0867 Chinyorwa 1.0 Peji 1 re2

UL Medical uye Regulatory Services UL, LLC ndeye MDSAP Inozivikanwa Kuongorora Sangano

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

UL uye iyo logo yeLU zviratidzo zve Underwriters Laboratories Inc. © 2011.

CERTIFICATE YOKUNyoresa

TEKNA Kugadzira Pvt. Ltd.

C-19, Industrial Estate, Guindy Chennai, Tamil Nadu 600032 INDIA

Zvimwe Zvekudzora zvinodiwa

REPs Nzvimbo ID:

Ositireriya:
- Therapeutic Goods (Medical Devices) Mitemo, 2002, Chirongwa 3 Chikamu 1 (kusasanganisira Chikamu 1.6) - Yakazara Hunhu Assurance Maitiro

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

Kanada:
- Medical Devices Mitemo - Chikamu 1- SOR 98/282

Japani:
- MHLW Ministerial Odinensi 169, Chinyorwa 4 kusvika Chinyorwa 68 - PMD Mutemo (, sezvazvinoshanda)

Nyika dzakabatana:

• - 21 CFR 820

• - 21 CFR 803

• - 21 CFR 806

  - 21 CFR 807 - Inoparadzira A kusvika D

- 21 CFR 821 (pazvinoshanda)

Faira Nhamba Chitupa Nhamba Yekutanga Nyaya Yakaburitswa Zuva

A28843 3017.200413 Kubvumbi 13, 2020

Kutenderera Kwokutanga Zuva Rinoshanda Zuva Rokupera Zuva

Kubvumbi 13, 2020 Kubvumbi 13, 2020 Kubvumbi 12, 2023

Iyi yehunhu system kunyoreswa inosanganisirwa muLL Directory yeVanyoresa maFemu uye inoshanda kune kupihwa kwezvinhu uye / kana masevhisi sezvakatsanangurwa muchiyero chekunyoresa kubva kukero (es) inoratidzwa pamusoro. Nekuburitswa kweichi chitupa iyo firm inomiririra kuti ichachengetedza kunyoreswa kwayo zvinoenderana nezvinodiwa. Chitupa ichi hachichinjwe uye chinoramba chiri chivakwa cheUL Medical uye Regulatory Services yeL LLC.

Zvitifiketi zvinogona kusimbiswa nekushanyira iyo Online Certification Dhairekitori pane UL.com.

00-MB-F0867 Chinyorwa 1.0 Peji 2 re2

UL Medical uye Regulatory Services UL, LLC ndeye MDSAP Inozivikanwa Kuongorora Sangano

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

UL uye iyo logo yeLU zviratidzo zve Underwriters Laboratories Inc. © 2011.