Certificates and Compliance
Drucker Diagnostics develops, designs, manufacturers, and supports premier laboratory equipment that are provided for clinical, diagnostic, research, and general laboratory applications across Europe.
Where applicable, select models comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 and corresponding UK regulatory requirements, while other general-purpose laboratory centrifuges conform to applicable European and UK requirements for electrical safety, electromagnetic compatibility, machinery, and environmental compliance. This framework ensures our products are designed and manufactured to meet the requirements for safe and effective use throughout these markets.
BSI ISO 13485:2016 Certificate of RegistrationRegulatory Compliance Matrix
| Framework & Directive | Compliance Scope & Status | Technical Certification Details |
|---|---|---|
| ISO 13485:2016 | Certified QMS | BSI Certificate No. FM 507511, registered through May 5, 2028, under Graeme Tunbridge (Senior Vice President, Global Regulatory & Quality, BSI). |
| IVDR Compliance | Class A Certified | Compliant with applicable requirements of IVDR (EU) 2017/746 for clinical laboratory diagnostic separations. |
| CE & UKCA Marks | Fully Conformant | CE marked and, where applicable, UKCA marked in accordance with relevant European Union and United Kingdom regulatory requirements. |
| RoHS / WEEE | Compliant Directives | Manufactured using lead-free processes. Compliant with applicable RoHS and WEEE requirements. |
| Electrical Grid Compatibility | Universal Input | International (Intl) configurations support 100-240 VAC (± 10%) universal voltage at 50/60 Hz, pre-fitted with local EU power cables. |
Compliance & European Service FAQ
Drucker Diagnostics has partnered with Poly Temp Scientific BV (Bolsward, Netherlands) to serve as our authorized local service and support provider for EU and UK clients. This established partnership ensures localized, rapid turnaround times for preventative maintenance, inspection, repair, and verification activities, eliminating international transit overhead.
Authorized depot service inquiries can be coordinated directly with Drucker Diagnostics via [email protected]. Customer service cases are processed and routed to the certified Netherlands facility to manage local return logistics, depot repairs, and certified parts replacement.
Drucker Diagnostics units purchased in Europe are backed by a comprehensive 2-year limited unit warranty. This covers parts and labor performed by certified service specialists.
Yes, local distributors coordinate the 30-day evaluation program. This allows European laboratories and hospitals to trial Drucker configurations on-site to evaluate workflow suitability, sample processing performance and laboratory compatibility prior to a procurement commitment.
Need Compliance Certificates or Evaluation Support?
For ISO certificates, IVDR Class A declaration or conformity, regional distributor details, fill out the form below or contact our support desk directly at [email protected].
To initiate a 30-day trial unit, please visit https://druckerdiagnostics.com/eu/try-risk-free/.
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