European Medical Device Directive 93/42/EEC
B Medical Systems S.à r.l. is certified according to the harmonized European Quality Management System Standards for Medical Devices EN ISO 13485 under the Regulatory Framework of the European Medical Device Directive 93 / 42 / EEC. All devices manufactured by B Medical Systems S.à r.l. are classified as medical devices according to the MDD 93/42/EEC and are therefore labeled with the CE or CE0123 markings if Class I or Class IIa, respectively.
The products from the Blood Management Solutions range, e.g. blood bank refrigerators, plasma storage freezers, and contact shock freezers are intended for the storage or processing of blood components and therefore are classified as medical devices Class IIa.
The products from the Medical Refrigeration range, e.g. laboratory and pharmacy refrigerators as well as laboratory freezers, are classified as Class I devices.
Why the ISO 13485 certification?
The ISO 13485 Standards establish requirements for a comprehensive quality management system for the design and manufacture of medical devices. Compliance with these Standards is a regulatory requirement for the production of medium and high-risk medical devices and it demonstrates that an organization is able to design and produce medical devices, as well as provide related services while meeting high safety standards for end-users and patients.
Our range of Medical Devices Class IIa:
- Blood Bank Refrigerators – B range
- Plasma Storage Freezers – Fxx1 range
- Blood Transport Boxes – MT range
- Ultra Low Freezers – U range
- Contact Shock Freezers – CSF range
Our range of Medical Devices Class I:
- Laboratory Refrigerators- L and ML ranges
- Laboratory Refrigerator/ Freezer – LF range
- Pharmacy Refrigerators – P and MP ranges
- Pharmacy Refrigerators/Freezers – PF range
- Laboratory Freezers- Fxx0 range
FDA (U.S. Food and Drug Administration) 21 CFR 820.
B Medical Systems is compliant with FDA (U.S. Food and Drug Administration) 21 CFR 820.
All our devices are 510 K exempt and classified into one of the following regulatory classes, depending on the product:
Class I acc. to FDA regulation 21 CFR part 862.2050 or class II acc. to FDA regulation 21 CFR Part 864.9700.
Our Standards of Compliance – Depending on the Product
B Medical Systems products are also compliant with different standards depending on the product.
Vaccine Cold Chain Certifications
All Cold Chain devices are classified as Medical Devices class I.
B Medical Systems Vaccine Cold Chain range comprises many products PQS-certified by WHO and 9 of them are CCEOP-eligible for Gavi – the Vaccine Alliance.
Certificate ISO 9001 (pdf)
Certificate ISO 14001 (pdf)
Certificate ISO 13485 (pdf)
Should you need more information, please contact our team.