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Manufacturer of orthopedic implants and surgical instruments based in Kladno, Czech Republic since 1992.
CzechiaFounded 1992Healthcare ManufacturerISO 13485CE certification (Class I, IIb, III)ISO 9001
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EU Quality Management System Certificate issued by 3EC International (Notified Body 2265) to BEZNOSKA, s.r.o. for the ELiS Total Trapezium-Metacarpal Joint Replacement system under Regulation (EU) 2017/745.
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EU Technical Documentation Assessment Certificate issued by 3EC International for the ELiS Total Trapezium-Metacarpal Joint Replacement system, confirming compliance with Regulation (EU) 2017/745.
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EC Certificate for Full Quality Assurance System issued by Elektrotechnický zkušební ústav for Beznoska, s.r.o. covering the design, manufacturing, and final inspection of ancillary components for the SVR Total Revision Knee Replacement system.
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EC Design-Examination Certificate for total knee joint replacement devices, issued by the Electrotechnical Testing Institute (Notified Body No. 1014) to Beznoska, s.r.o. under Directive 93/42/EEC.
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EC Certificate for Full Quality Assurance System issued to Beznoska, s.r.o. for the design, manufacturing, and final inspection of Total knee joint replacement (Class III).
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EC Certificate for Full Quality Assurance System issued to Beznoska, s.r.o. for the design, manufacturing, and final inspection of hip joint replacement (hemiarthroplasty and ancillary components) class IIb.
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EC Design-Examination Certificate for Total hip joint replacement (class III) issued by the Electrotechnical Testing Institute (Notified Body No. 1014) to Beznoska s.r.o. in accordance with Directive 93/42/EEC.
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EC Certificate for Full Quality Assurance System issued by the Electrotechnical Testing Institute (EZÚ) to Beznoska, s.r.o. for the design, manufacturing, and final inspection of Total hip joint replacement (Class III).
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EC Certificate for Full Quality Assurance System according to Directive 93/42/EEC, Annex II, excluding Section 4, issued by TÜV Rheinland for Changzhou Medical Bioengineering Co., Ltd.
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EC Certificate for Production Quality Assurance System under Directive 93/42/EEC Annex V for Disposable Electronically Pulsed Lavage Suction Apparatus.
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EU Quality Management System Certificate issued to TEKNIMED SAS under Regulation (EU) 2017/745 (MDR), covering various classes of implantable devices including bone cements, bone substitutes, and osteosynthesis implants.
certificate ce
EU Quality Management System Certificate issued by 3EC International (Notified Body 2265) to BEZNOSKA, s.r.o. for the ELiS Total Trapezium-Metacarpal Joint Replacement system under Regulation (EU) 2017/745.
certificate ce
EU Technical Documentation Assessment Certificate issued by 3EC International for the ELiS Total Trapezium-Metacarpal Joint Replacement system, confirming compliance with Regulation (EU) 2017/745.
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Instructions for use for Beznoska cementless hip stems, including SF, RMD, and Trio models. Covers product descriptions, material specifications (ISO 5832-3, ISO 5832-2, ISO 13779-2, ISO 5832-12), indications, contraindications, surgical warnings, and post-operative care.
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Instructions for use for Beznoska cemented acetabular cups, covering handling, indications, contraindications, surgical procedure, and post-operative care. Includes information on sterility, material composition (UHMWPE and stainless steel), and compatibility with Beznoska hip heads.
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Instructions for use for Beznoska hip joint heads (metal and ceramic), covering indications, contraindications, surgical procedures, warnings, and sterilization information for total hip replacement systems.
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Instructions for use for the Beznoska Cervical-Capital Endoprosthesis product group, including stems, metal heads, bi-articular heads, and centralizers. Covers indications, contraindications, surgical warnings, sterilization, and disposal.
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Instructions for use for a group of cemented hip stems and auxiliary components including centralizers, collars, plugs, and cerclage systems. Covers indications, contraindications, surgical warnings, and post-operative care.
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Instructions for use for Beznoska cementless acetabular cups, including SF/II, TC/II, and DUO models. Covers indications, contraindications, surgical warnings, sterilization, and post-operative care.
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Instructions for use for Beznoska auxiliary items, specifically K-wires and Osteofix wires, used in total hip replacement and bone fragment fixation. Includes details on material (ISO 5832-1), sterilization, surgical handling, contraindications, and warnings.
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Instructions for use for the ELiS Total Trapezium-Metacarpal Joint Replacement, covering indications, contraindications, surgical procedure, material composition, and patient safety information.
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A comprehensive guide defining the symbols used on medical device packaging and labeling, compliant with ISO 15223-1 and ISO 7010 standards.
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A comprehensive guide defining the symbols used on medical device packaging and labeling, compliant with ISO 15223-1 and ISO 7010 standards.
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Instruction for use for the ELiS Total Trapeziometacarpal Joint Replacement system, covering indications, contraindications, surgical procedure warnings, and material specifications for stems, necks, cups, and trapezium replacements.