Certified Management Systems
EN ISO 13485, ISO 9001, and MDD Annex II excl. 4
Certificate Holder: ALVO Spółka z ograniczoną odpowiedzialnością Sp. K.
Test Mark Number: 9108650751
The certificate holder's Management System corresponds to standards:
- ISO 13485:2016
- ISO 9001:2015
The organization "ALVO Spółka z ograniczoną odpowiedzialnością Sp. K." as named in the certificate was audited and certified by “TÜV Rheinland Polska“.
Certificate scopes:
-
EN ISO 13485:
Design, development, production, installation and servicing of patient handling devices, related accessories, retractor systems, luminaires for diagnosis and surgery and software working in combination with related
infrastructure for managing and integration of equipment and medical devices in an operating room. -
ISO 9001:
Design, development, production, installation and service of metal and glass products, patient handling devices, related accessories, retractor systems, as well as management and integration systems of medical devices and products of an operating room.
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MDD Annex II excl. 4:
-Surgical retractors
Replaces EC Certificate, Registration No.: HD 60095410 0001
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ALVO Spółka z ograniczoną odpowiedzialnością Sp. K. Południowa 21A 64-030 Śmigiel Poland |