ISO13485

The quality management system ISO13485:2016 , issued by NQA ( UKAS), specially for the micro needling system and electric micro needling system.

Certificate includes factory annual inspection, also with the inspection report( Chinese version).Based on the certificate, manufacturer is available to issue the inspection report of the finished product, as well as the product sterilization report according to the customer demands.

 

 

CE1282 & ROHS

Issued by ECM ,at medical device directive 93/42/EEC, technical stands: EN ISO10993-1:2009     EN ISO10993-10:2013    EN ISO10993-12:2012.

This certificate is for passive products, that means the products without electric power.

 

ROSH at directive IEC 62321-5:2013   IEC 62321-4:2013   IEC 62321:2008  IEC 62321-6:2015

 

INMETRO

The necessary certificate that export to Brazil market. Specially for the active products, which means the product  with electric power.

Tested and reported by SGS, technical stands: IEC60601-1k    IEC60601-1-11c    IEC60601-1-2:2007    IEC60601-1-6h

The adaptor approved by UL and FCC ( for US/EU/UK plug), EN14136 ( special for Brazil market plug)

Based on this certificate, and SGS demands, special inspections are necessary, which includes : Type of high-voltage insulation test Records and Type of Leakage Current and Test Condition Records

 

ANVISA

The necessary certificate that export to Brazil market.

 

EU-REP

European Authorized Representative

Company:  SUNGO Europe B.V.

Add:           Olympisch Stadion 24, 1076DE, Amsterdam, Netherlands

Email:         EC.REP@sungogroup.com

Phone:        +31 08 5029 0204

 

CIBG

Product registration in Europe.

 

 

 

Class ⅡMedical Device Business Certificate

 

FSC ( Free Sales Certificate)

MSDS

For derma roller and derma pen report

Certificate of Patent