Certificate EC MEDGAL-HIP ENDOPROSTHESIS
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EC Certificate No. 1434-MDD-063/2021 Full Quality Assurance System Directive 93/42/EEC concerning medical devices Polish Centre for Testing and Certification certifies that the quality assurance system in the organization: Medgal Sp. z o.o. ul. Niewodnicka 26A, 16-001 Księżyno Poland for the design, manufacture and final inspection of medical devices, class IIb MEDGAL-HIP ENDOPROSTHESIS The list of medical devices covered by this certificate is provided in the annexes 1-4 complies with requirements of Annex II (excluding Section 4) to Directive 93/42/EEC (as amended) implemented into Polish law, as evidenced by the audit conducted by the PCBC Validity of the Certificate: from 01.02.2021 to 27.05.2024 The date of issue of the Certificate: 01.02.2021 The date of the first issue of the Certificate: 24.03.2021 Issued under the Contract No. MD-111/2019 Application No: 241/2020 Certificate bears the qualified signature. Warsaw, 01/02/2021 Module H2/3/4/5 Anna Małgorzata Wyroba Elektronicznie podpisany przez Anna Małgorzata Wyroba Data: 2021.02.01 12:21:18 +01'00' POLISH CENTRE FOR TESTING AND CERTIFICATION 02-844 Warsaw, 469 Puławska Street, tel. +48 22 46 45 200, e-mail:pcbc@pcbc.gov.

ANNEX 1 TO THE CERTIFICATE VALID ONLY WITH CERTIFICATE No 1434-MDD-063/2021 List of medical devices covered by the certificate: Nr REF 1-35-07-[01÷11] 4-35-07-[01÷11] 1-35-07-[01÷11].C 4-35-07-[01÷11].C Description Cemented ST 135 Cemented ST 135 with centralizer Device parameters Size from 1 to 11 (step 1) Size from 1 to 11 (step 1) Cemented ST 138 Cemented ST 138 with centralizer Size from 0 to 14 (step 1) Size from 1 to 11 (step 1) Size from 1 to 11 (step 1) STANDARD Stem Cemented CV 125 Cemented CV 125 with centralizer Size from 0 to 14 (step 1) Size from 1 to 11 (step 1) Size from 1 to...

ANNEX 2 TO THE CERTIFICATE VALID ONLY WITH CERTIFICATE Device parameters Metal 22 Size M, L, XL, XXL Metal 22,2 Femoral Head Metal 26 Size S, M, L, XL, XXL, XXXL Metal 28 Head Shell For Femoral Head 22 For Femoral Head 22,2 Polyethylene For Femoral Head 26 Liner For Femoral Head 28 For Femoral Head 32 For Femoral Head 22 For Femoral Head 22,2 Locking Ring For Femoral Head 26 For Femoral Head 28 For Femoral Head 32 For Femoral Head 22 Polyethylene For Femoral Head 22,2 Liner PressFor Femoral Head 26 Fit For Femoral Head 28 For Femoral Head 32 Size from 40 to 73 (step 1) Size from 43 to 73...

ANNEX 3 TO THE CERTIFICATE VALID ONLY WITH CERTIFICATE Issued under the Contract No. MD-111/2019 Application No: 241/2020 Certificate bears the qualified signature. Warsaw, 01/02/2021 Description For Femoral Head 22 For Femoral Head 22,2 For Femoral Head 26 For Femoral Head 28 For Femoral Head 32 For Femoral Head 22 For Femoral Head 22,2 For Femoral Head 26 For Femoral Head 28 For Femoral Head 32 For Femoral Head 22 For Femoral Head 22,2 For Femoral Head 26 For Femoral Head 28 For Femoral Head 32 For Femoral Head 22 For Femoral Head 22,2 For Femoral Head 26 For Femoral Head 28 For Femoral...

ANNEX 4 TO THE CERTIFICATE VALID ONLY WITH CERTIFICATE No 1434-MDD-063/2021 List of medical devices covered by the certificate: Nr REF 4-31-11-[38÷65] 103-31-11-[38÷65] 4-31-12-[38÷65] 103-31-12-[38÷65] 4-31-13-[38÷65] 103-31-13-[38÷65] 4-31-14-[38÷65] 103-31-14-[38÷65] 4-31-15-[38÷65] 103-31-15-[38÷65] Description Size S Size M Unipolar Head Size L Size XL Size XXL Device parameters Size from 38 to 65 (step 1) Size from 38 to 65 (step 1) Size from 38 to 65 (step 1) Size from 38 to 65 (step 1) Size from 38 to 65 (step 1) Material Stainless steel Cobalt alloy Stainless steel Cobalt alloy...