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EC Certificate MDR EMG EP Surpass and Surpass LT QS 055
1 /4Pages

 EC Certificate MDR EMG EP Surpass and Surpass LT QS 055

EC Certificate MDR EMG EP Surpass and Surpass LT QS 055
1 /4Pages

Catalog excerpts

 EC Certificate MDR EMG EP Surpass and Surpass LT QS 055-1

3EC International a. s., Hranidna 18, 821 05 Bratislava, Slovak Republic EMS Handels Gesellschaft m.b.H. Jochingergasse 1, 2100 Korneuburg, Austria SRN No.: AT-MF-000002599 This EU Quality Management System Certificate issued in accordance with the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices as amended confirms, that quality management system of medical device: Electromyograph and Evoked Potential Equipment Models: see Annex I Intended purpose: see Annex II MD class lla / rule 10 (detailed list is stated in the annex(es) if applicable) meets the requirements on quality management system according to the Chapter I and III of Annex IX of the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices as amended. Conditions for or limitations to the validity of the certificate: N/A Validity of the certificate is conditional upon positive results of regular surveillance audits. Notified body No. 2265 has performed assessment of the quality management system of the abovementioned medical device and found that it meets the requirements stated above. The outcome of the assessment of the quality management system of the abovementioned medical device is stated in the Technical Documentation Assessment Report No. MDR454_2024 from 12.11.2025, Clinical Evaluation Report No. MDR454_2024 from 12.11.2025 and Audit Report No. SK-0534/25 from 02.04.2025. Information on all examinations and tests performed is stated in the abovementioned reports and is available on request. This EU Quality Management System Certificate applies only to the quality management system of the abovementioned medical device. The certificate validity is conditional upon fulfilment of relevant legal requirements by the manufacturer. Valid from: 12.11.2025 Valid until: 19.06.2029 First issue: 12.11.2025 Revision: 00 History: see Annex III 3EC International a. s. Katarina Tomin Srdo§ova, PhD. ©TlaClarert centn KASICO, a. 8. Bratislava, KC25-00124

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 EC Certificate MDR EMG EP Surpass and Surpass LT QS 055-2

Jochingergasse 1, 2100 Korneuburg, Austria List of medical devices covered by the EU Quality Management System Certificate: atarina Tomin SrdoSova, PhD. In Bratislava, Slovakia, 12.11.2025 Valid until 19.06.2029 ©TlaCiarart cenfn KASICO, a. s. Bratislava, KC25-00124

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 EC Certificate MDR EMG EP Surpass and Surpass LT QS 055-3

Jochingergasse 1, 2100 Korneuburg, Austria The Surpass and the Surpass LT Electromyograph and Evoked Potential Equipment is used to diagnose and monitor neuromuscular disorders and to measure, record and analyse the electrical activity of muscles. ^TovAHb-atarina Tomin Srdoiovd, PhD. In Bratislava, Slovakia, 12.11.2025 Valid until 19.06.2029 ©TlaCiarefl canln KAS1CO, a. s. Bratislava, KC25-00124

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 EC Certificate MDR EMG EP Surpass and Surpass LT QS 055-4

Jochingergasse 1, 2100 Korneuburg, Austria Certificate history Katarina Tomin Srdo§ova, PhD. In Bratislava, Slovakia, 12.11.2025 Valid until 19.06.2029 ©TlaCiaraft cenfn KASlCO, a. s. Bratislava, KC25-00124

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