PILI O LE FAITAUINA

TEKNA Manufacturing Pvt. Ltd.

C-19, Esetete Alamanuia, Guindy Chennai, Tamil Nadu 600032 INITIA

UL Medical Regulatory Services a le UL LLC®(UL) tuuina atu lenei tusi faamaonia i le Kamupani ua taua i luga, pe a uma ona suʻeina le faiga o pulega lelei a le Kamupani ma maua i le ogatusa i le lautele ua faʻamatalaina e tusa ai ma:

ISO 13485: 2016

fa'atasi ai ma mana'oga fa'atulafonoina fa'aopoopo o lo'o lisiina ile itulau mulimuli o lenei tusi pasi. Le mamanu, gaosiga, tautua ma le faʻapipiʻiina o potu hyperbaric.

Faʻamaonia e

Michael J. Windler, PE Pule o le Global Regulatory Service Sui mamalu o le Aufaigaluega Faʻatekinisi UL Life and Health Sciences
UL LLC

Siaki Tusi Faamaonia

Tulaga: iinei

ID Fa'atonu a REPs:

Numera faila Numera Tusi Faamaonia Aso Fa'amatalaga Muamua

A28843 3017.200413 Aperila 13, 2020

Ta'amilosaga Aso Amata Aso Fa'agata Aso Fa'amutaina

Aperila 13, 2020 Aperila 13, 2020 Aperila 12, 2023

O lenei faiga lelei resitalaina o loʻo aofia i le UL's Directory of Registered Firms ma faʻaoga i le tuʻuina atu o oloa ma / poʻo auaunaga e pei ona faʻamaonia i le lautele o le resitalaina mai tuatusi(es) o loʻo faʻaalia i luga. O le tu'uina atu o lenei tusipasi ua fa'ailoa mai ai e le kamupani o le a fa'atumauina lona resitala e tusa ai ma mana'oga talafeagai. O lenei tusi pasi e le mafai ona fa'aliliuina ma tumau pea le meatotino a le UL Medical and Regulatory Services a le UL LLC.

E mafai ona fa'amaonia tusi pasi ile asiasi ile Online Certifications Directory ile UL.com.

00-MB-F0867 Lomiga 1.0 Itulau 1 o le 2

UL Medical and Regulatory Services UL, LLC o se MDSAP Recognized Suetusi Faalapotopotoga

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

UL ma le logo UL o fa'ailoga fa'ailoga a Underwriters Laboratories Inc. © 2011.

PILI O LE FAITAUINA

TEKNA Manufacturing Pvt. Ltd.

C-19, Esetete Alamanuia, Guindy Chennai, Tamil Nadu 600032 INITIA

Tulafono Fa'aopoopo Manaoga

ID Fa'atonu a REPs:

Ausetalia:
– Tulafono Fa'atonu o Mea Fa'afoma'i (Meafaigaluega Fa'afoma'i), 2002, Fa'amatalaga 3 Vaega 1 (e le aofia ai le Vaega 1.6) - Ta'aloga Fa'amautinoaga Tulaga Atoa.

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

Kanata:
– Tulafono Faatonutonu o Mea Faafomai – Vaega 1- SOR 98/282

Iapani:
– Tulafono a Minisita MHLW 169, Mataupu 4 i le Mataupu 68 – Tulafono o le PMD (, pe a talafeagai ai)

Amerika Tele:

• – 21 CFR 820

• – 21 CFR 803

• – 21 CFR 806

  – 21 CFR 807 – Vaega laiti A i le D

– 21 CFR 821 (pe a talafeagai ai)

Numera faila Numera Tusi Faamaonia Aso Fa'amatalaga Muamua

A28843 3017.200413 Aperila 13, 2020

Ta'amilosaga Aso Amata Aso Fa'agata Aso Fa'amutaina

Aperila 13, 2020 Aperila 13, 2020 Aperila 12, 2023

O lenei faiga lelei resitalaina o loʻo aofia i le UL's Directory of Registered Firms ma faʻaoga i le tuʻuina atu o oloa ma / poʻo auaunaga e pei ona faʻamaonia i le lautele o le resitalaina mai tuatusi(es) o loʻo faʻaalia i luga. O le tu'uina atu o lenei tusipasi ua fa'ailoa mai ai e le kamupani o le a fa'atumauina lona resitala e tusa ai ma mana'oga talafeagai. O lenei tusi pasi e le mafai ona fa'aliliuina ma tumau pea le meatotino a le UL Medical and Regulatory Services a le UL LLC.

E mafai ona fa'amaonia tusi pasi ile asiasi ile Online Certifications Directory ile UL.com.

00-MB-F0867 Lomiga 1.0 Itulau 2 o le 2

UL Medical and Regulatory Services UL, LLC o se MDSAP Recognized Suetusi Faalapotopotoga

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

UL ma le logo UL o fa'ailoga fa'ailoga a Underwriters Laboratories Inc. © 2011.