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Certificate of CE Registration (Authorized Representatives)
European Authorized Representative
[ March 5th, 2021 ]
Switzerland Authorized Representative
[ January 5th, 2022 ]
United Kingdom Responsible Person
[ February 17th, 2021 ]
EC Certificate
Full Quality Assurance
[ Annex II ]
EC_Certificate_MDD_93_42_EEC_Annex_V.pdf
[ Annex V ]
ISO 13485:2016 Certificate of Registration
ISO 13485:2016 Certificate of Registration
Medical Device Single Audit Program (MDSAP) Certificate
Medical Device Single Audit Program
[ (MDSAP) Certificate ]
Declarations of Conformity – MDD
Sterile and Non-sterile Needle Guides and Non-sterile Brackets
[ April 6th, 2021 ]
Sterile and Non-sterile Drapes/Covers (Class IIa)
[ April 6th, 2021 ]
Sterile and Non-sterile Standoffs/Couplants
[ March 18th, 2021 ]
Sterile Needle Guide (Template Grid)
[ March 18th, 2021 ]
Sterile and Non-sterile Drapes/Covers (Class I)
[ March 18th, 2021 ]
Electromagnetic Tracking System
[ March 16th, 2021 ]
Declarations of Conformity – MDR
Manual Steppers
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CIVCO Medical Solutions
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Products
Ultrasound Probe Covers
Probe Cleaning & Disinfection
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