Akwụkwọ nke ndebanye aha

TEKNA n'ichepụta Pvt. Ltd.

C-19, Industriallọ Ọrụ, Guindy Chennai, Tamil Nadu 600032 INDIA

Ọrụ UL Medical Regulatory Services nke UL LLC® (UL) na-ewepụta akwụkwọ a na ụlọ ọrụ ahụ akpọrọ aha n'elu, mgbe nyochachara usoro njikwa njikwa nke Firm na ịchọta ya na mmezu ọ bụla akọwapụtara maka:

ISO 13485: 2016

na usoro nchịkwa ndị ọzọ edepụtara na ibe ikpeazụ nke akwụkwọ a. Imewe, imepụta, ọrụ na ntinye nke ụlọ hyperbaric.

Onye nyere ikike

Michael J. Windler, Pee Manager nke Global Regulatory Service Na-akwanyere ùgwù Onye otu Ndị Ọrụ Nka na ụzụ UL Life and Health Sciences
UL UL

Lelee Asambodo

Ọnọdụ: ebe a

NJ ID ID:

Nọmba Asambodo Nọmba Asambodo Bụ Nke Mbụ

A28843 3017.200413 Eprel 13, 2020

Cycle Datebọchị Mbido Ọgwụgwụ Expbọchị Mmebi

Eprel 13, 2020 Eprel 13, 2020 Eprel 12, 2023

Ndebanye aha sistemụ a dị mma dị na UL's Directory of Firms Firms ma metụta ịnye ngwaahịa na / ma ọ bụ ọrụ dịka akọwapụtara n'ogo nke ndebanye aha site na adreesị (es) egosiri n'elu. Site na inye akwụkwọ a ụlọ ọrụ ahụ na-anọchite anya ya ga-edebanye aha ya n'akwụkwọ dịka ihe ndị achọrọ dị. Akwụkwọ a enweghị ike ịfefe ma bụrụ akụ nke UL Medical and Regulatory Services of UL LLC.

Enwere ike ikwenye asambodo site na ịga na Akwụkwọ Asambodo Ntanetị na UL.com.

00-MB-F0867 Esemokwu 1.0 Page 1 nke 2

UL Medical and Regulatory Services UL, LLC bụ MDSAP amatara Auditing Organization

UL LLC 333 Pfingsten Okporo ụzọ Northbrook, IL 60062-2096 USA

UL na UL logo bụ ụghalaahịa nke Underwriters Laboratories Inc. © 2011.

Akwụkwọ nke ndebanye aha

TEKNA n'ichepụta Pvt. Ltd.

C-19, Industriallọ Ọrụ, Guindy Chennai, Tamil Nadu 600032 INDIA

Agbakwunyere Regulatory chọrọ

NJ ID ID:

Australia:
- Ngwaahịa ọgwụgwọ (Ngwaọrụ Ahụike) Iwu, 2002, Nhazi oge 3 Nkebi 1 (ewepu Nkebi nke 1.6) - Usoro nkwenye zuru ezu.

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

Canada:
- Usoro Iwu Ahụike - Nkebi nke 1 - SOR 98/282

Japan:
- MHLW Iwu Minista 169, Nkeji edemede 4 na Nkeji edemede 68 - PMD Act (, dịka o siri dị)

United States:

• - 21 CFR 820

• - 21 CFR 803

• - 21 CFR 806

  - 21 CFR 807 - Akụkụ A ruo D

- 21 CFR 821 (ebe odi)

Nọmba Asambodo Nọmba Asambodo Bụ Nke Mbụ

A28843 3017.200413 Eprel 13, 2020

Cycle Datebọchị Mbido Ọgwụgwụ Expbọchị Mmebi

Eprel 13, 2020 Eprel 13, 2020 Eprel 12, 2023

Ndebanye aha sistemụ a dị mma dị na UL's Directory of Firms Firms ma metụta ịnye ngwaahịa na / ma ọ bụ ọrụ dịka akọwapụtara n'ogo nke ndebanye aha site na adreesị (es) egosiri n'elu. Site na inye akwụkwọ a ụlọ ọrụ ahụ na-anọchite anya ya ga-edebanye aha ya n'akwụkwọ dịka ihe ndị achọrọ dị. Akwụkwọ a enweghị ike ịfefe ma bụrụ akụ nke UL Medical and Regulatory Services of UL LLC.

Enwere ike ikwenye asambodo site na ịga na Akwụkwọ Asambodo Ntanetị na UL.com.

00-MB-F0867 Esemokwu 1.0 Page 2 nke 2

UL Medical and Regulatory Services UL, LLC bụ MDSAP amatara Auditing Organization

UL LLC 333 Pfingsten Okporo ụzọ Northbrook, IL 60062-2096 USA

UL na UL logo bụ ụghalaahịa nke Underwriters Laboratories Inc. © 2011.