ID No. 0000023768: SORIMEX Spółka z ograniczoną odpowiedzialnością Sp. k.

The certificate holder's Management System corresponds to standards:

  • ISO 13485:2003
  • ISO 9001:2008
The organization "SORIMEX Spółka z ograniczoną odpowiedzialnością Sp. k." as named in the certificate was audited and certified by “TÜV Rheinland LGA Products GmbH“.
Certificate scopes:
  • QMS:
    (see attachment for scope included) Design and development, manufacture and distribution of disposable and reusable SpO2 sensors, disposable and reusable temperature probes, NIBP cuffs, NIBP cuffs adapters, SpO2 probes cables, SpO2 probes adapters, temperature probes cables, ECG electrodes, ECG cables and wires, ECG adapters and electrocardiographs
  • QMS Normenkonformität:
    (see attachment for scope included) Design and development, manufacture and distribution of disposable and reusable SpO2 sensors, disposable and reusable temperature probes, NIBP cuffs, NIBP cuffs adapters, SpO2 probes cables, SpO2 probes adapters, temperature probes cables, ECG electrodes, ECG cables and wires, ECG adapters and electrocardiographs
  • Vollst. QMS, Anhang II MDD:
    (see attachment for products included) Replaces Approval, Registration No.: HD 60036768 0001 Products included: - Disposable SpO2 sensors - Reusable SpO2 sensors - Disposable temperature probes - Reusable temperature probes - Electrocardiographs
Description:

SORIMEX Spółka z ograniczoną odpowiedzialnością Sp. k. holds a certified quality management system according to EC Directive 93/42/EEC-MDD Annex II (except section 4), EN ISO 13485:2003+AC:2009 and EN ISO 9001:2008 for design and development, production and distribution of SpO2 sensors, temperature probes, ECG and EEG electrodes, patient cables and accessories for medical devices. The quality management system of SORIMEX Spółka z ograniczoną odpowiedzialnością Sp. k. is subject to regular, annual monitoring by TÜV Rheinland Group.

Further information by the certificate holder: The certificate holder has not provided further information.
Contact to the certificate holder: SORIMEX Spolka z ograniczona
odpowiedzialnoscia Sp. k.
ul. Równinna 25
87-100 Torun
Poland
E-mail: sormed@sorimex.pl