Plasma Storage Solutions

Description

Certified Excellence in Medical Refrigeration

All Thalheimer devices are developed and manufactured in compliance with the most stringent international medical device regulations and standards:

• ISO 13485:2016 Certified – Audited and certified by DQS Medizinprodukte GmbH (Certificate No. 534217 MP2016) for the design, production, and servicing of medical refrigerators and freezers, valid until October 2026.
• EU Medical Device Regulation (MDR) 2017/745 – Full transition underway with extended certification validity until December 2028 for Class IIa devices under Regulation (EU) 2023/607.
• IEC 60601-1 – Safety and performance standards for medical electrical equipment.
• EN 60068-2-1/-2 – Environmental testing for operational reliability.
• ISO 21969 – Specific requirements for blood refrigeration equipment.
• EU GMP Annex 15 – Compliance guidelines for pharmaceutical-grade storage.

Advanced Product Portfolio

Our solutions include:

• Haemo med line (+4°C) – Precision blood bank refrigerators with advanced temperature uniformity.
• Cryo med line (-80°C) – Ultra-low freezers for plasma, vaccines, and biopharmaceuticals.
• Frezo med line (down to -40°C) – High-performance freezers for diagnostic samples and reagents.

Trusted by healthcare professionals worldwide, Thalheimer Kuehlung GmbH & Co.KG  delivers intelligent, compliant refrigeration solutions designed for critical performance and long-term reliability.

 

✔ Dual Certification & MDR Expertise
CE-marked under MDD (93/42/EEC) and ISO 13485:2016 certified by DQS, with full MDR transition underway. Our dedicated MDR experts and PRRC (Person Responsible for Regulatory Compliance) ensure seamless compliance with EU Medical Device Regulation 2017/745.

✔ Regulatory Excellence
Compliant with FDA 21 CFR Part 11 (data integrity), WHO PQS, and global medical device standards. Our team navigates complex regulations so you don’t have to.

✔ Future-Proof Technology
Meets EU MDR UDI requirements for complete traceability and features the latest innovations in medical refrigeration technology.

✔ German Engineering Reliability
Robust, energy-efficient systems engineered for 24/7 critical operation, backed by Thalheimer’s renowned precision and durability.

 

✔ Full Regulatory Support
From MDR documentation to post-market surveillance, our regulatory team provides end-to-end compliance assurance.

Trusted by healthcare institutions globally, Thalheimer delivers precision, reliability, and compliance for critical cold chain applications.