Certifications & Compliance
Melpex Beauty Instruments is fully committed to meeting the highest international standards of quality, safety, and regulatory compliance. Our products are manufactured and managed under globally recognized certifications and registrations:
MDR (Medical Device Regulation) Compliance
Melpex Beauty Instruments is proud to confirm full compliance with the latest European Union Medical Device Regulation (EU MDR 2017/745), as amended by Regulation (EU) 2023/607 for “legacy” devices.
Our MDR status has been officially confirmed by the Ente Certificazione Macchine (ECM), Notified Body No. 1282 (Italy). This means our surgical instruments are legally authorized for distribution and sale in the European market under the current transitional provisions.
Key Compliance Details:
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Single Registration Number (SRN): PK-MF-000014031
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Notified Body: Ente Certificazione Macchine srl, NB 1282, Italy
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EU Regulation: MDR 2017/745 (including amendments of EU 2023/607 for legacy devices)
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Official EUDAMED Registration:
Regulatory Compliance
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EU MDR (Medical Device Regulation)
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SNR #: PK-MF-000014031
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UDI Compliant with HIBCC (Designated Issuing Agency as per EU MDR 2017/745 & FDA USA)
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CE Mark
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Reference No: CA 008497
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FDA (United States Food & Drug Administration)
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Registration No: 3005092287
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Quality Management Certifications
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ISO 9001:2015
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Registration No: PK/1739-B
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ISO 13485:2016
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Registration No: PK/1739-B
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