Certifications

What Sets Us Apart

Surgery
A Closer Look

Global Standard

We have acquired ISO 10993, ISO 14644-1 Class 8 Cleanroom and ISO 13485:2016 after working incessantly in the industry since 2009. These certifications have helped us build a very high level of trust with our clients as it has required us to go through lengthy testing and yield to rigorous safety standards. At Synertech Int'l Ltd, we’re committed to providing the best service in the industry, and it’s evident through our achievements.

Widely Approved

At Synertech Int'l Ltd, we believe in maintaining the highest possible standard in everything we do. We hold a number of approvals from different countries, including Canada, Australia, among others. We have gone through a very rigorous verification process and know that it will enhance our relationship with our clients even further.

 

Recognitions

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1

Important Info

Approved by DEKRA of Germany Conformity to Corona SARS-CoV2 respiratory protective mask:3419330-CPA

2

Key Facts

Health Canada COVID-19 Medical Device Interim Order Authorization Ref. No. for Importation & Sales in Canada : 313915, 315843, 320097, 322282 & 323146

3

Important Info

Australian Register of Therapeutic Good (ARTG) Entry No.: 338432, 342339 & 350650

4

Key Facts

US FDA Registration No.3017208273 & Device Listing for Face Mask under Product Code : QKR

5

Good to Know

SGS tested EN149:2001+A1:2009 FFP2 NR Level Standard with SGS FIMKO OY

6

Important Info

NB 0598 issued Module B EU Type-Examination Certificate & Module C2 Certificate

7

Key Facts

CNAS/ilac MRA accredited laboratory tested EN149:2001+A1:2009 FFP2 & FFP3 NR Level Standard and verifying with Universal Certification (NB 2163) for Module B EU Type-Examination Certificate & Module C2 Certificate

8

Good to Know

Nelson Lab tested ASTM F2100-19 Level 2 & 3 and EN 14683:2019 Type IIR Standard

9

Important Info

SGS tested GB 19083-2010 and GB 2626-2019 Standard

10

Key Facts

ISO 10993, ISO 14644-1 Class 8 Cleanroom and ISO 13485:2016 Certified

11

Good to Know

FDA 510K submission on the way, Hospitals and Clinics in United Kingdom, Spain, Australia, Canada, Hong Kong, Philippines are using our N95 standard mask