CE Marking for Surgical face masks
CE Marking
CE mark for Surgical Face mask as Class I medical device from EAR after Testing as Per EN 14683:2005
UK Responsible Person
UK Responsible Person
We as UK Responsible person established in the United Kingdom acts on behalf of a manufacturer under UK MDR 2019
EAR Services-(EU)
Authorized Representative
We monitor vigilance issues related to your product and are the contact person on your behalf for European authorities
US FDA Services
US FDA Registrations
Prior to exporting a Medical device in US it must be registered with US FDA . We Register both 510K exempt and 510K products with US FDA
Free Sales Certificate
Free Sales Certificate (FSC)
We provide Free Sales certificate (FSC) from EU-European Union country and UK for medical Devices from with apostle service.
EAR Services-(EU)
Authorized Representative
We monitor vigilance issues related to your product and are the contact person on your behalf for European authorities
ISO 13485:2016
ISO 13485:2016
ISO 13485 states the international standard requirements for a QMS specifically aimed for medical devices.
ISO 9001:2015
ISO 9001:2015
ISO 9001 helps organizations to ensure that high quality products and services is provided to their customers consistently, which in turn brings satisfied of customers as well as of management, and employees.
IEC 60601
IEC 60601 Pretesting
The IEC 60601-1 addresses risks associated with electronic medical devices –this standard has become a de facto requirement for most companies manufacturing electro-medical equipments.