CE ISO 13485:2016

CE

Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC — conformity to the safety and health requirements of the Directive.

Company
STEELENCE
Product(s)
Surgical Instruments, Dental Instruments, Beauty Instruments, Veterinary Instruments
Standards
93/42/EEC & Annex V / 2007/47/EEC Module A Annex VII for Class A & B Medical Devices
Note
Re-usable, non-powered and non-measuring devices (manufacturer’s declaration)
Issue date
15.09.2025
Expiry date
15.09.2026
Issued by
MLK International Certification and Education Services

ISO 13485:2016

Medical Devices — Quality Management System of STEELENCE assessed and found in accordance with ISO 13485:2016.

Company
STEELENCE
Scope
Manufacturing & Exporting of Surgical, Dental, Beauty and Veterinary Instruments
Initial registration
15.09.2025
Issue date
15.09.2025
Valid until
15.09.2026
Cycle
3 Years
Issued by
MLK International Certification and Education Services
Documents

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