Presafe is an accredited Certification Body and EU Notified Body for Medical Devices and Hazardous Area Equipment. This move reinforces DNV GL’s long-held position as a provider of high quality and trusted certification for European markets and beyond. Presafe will be owned by DNV GL - Business Assurance.
Presafe 0543 refers to Presafe Denmark A/S (Notified Body identification number 0543), a prominent Danish certification authority. Located in Hellerup, Denmark, they are accredited to audit, inspect, and issue CE marks for medical devices and personal protective equipment.If you have a medical device or safety product displaying the "CE 0543" mark, it means the manufacturer's quality systems and product designs were officially evaluated and approved by this specific agency.
Core Functions & Key Details Regulatory Authority:
Based in Denmark (formerly a joint venture between DNV and Nemko), Presafe Denmark assesses whether medical devices comply with European Union directives.
- CE Marking Authority: The "0543" designation means they are legally authorized to review technical files, conduct facility audits, and issue the certificates required for manufacturers to affix a CE mark.
- Key Details & Background Designation: It is a officially designated Notified Body by the European Union, authorized to conduct conformity assessments, quality system audits, and issue CE marks.
- Location: Tuborg Parkvej 8, 2900 Hellerup, Denmark.
- Industry Specialization: Historically, the 0543 body focused heavily on the MDD (Medical Devices Directive), certifying a wide range of Class I, IIa, IIb, and III medical and in-vitro diagnostic products.
- Organizational Shift: In recent years, ownership operations were consolidated. Many medical device certificates formerly managed under Presafe Denmark (0543) have been transferred to DNV’s primary Notified Body in Norway (NB 2460) to comply with the European Medical Devices Regulation (MDR).
- Verification & Resources Official Registry: You can find its status and registration details on the BEUDAMED Database or the global Notify Body Database.
- Certificate Validity: To verify a specific CE or ISO certificate issued by this body, you must cross-reference the document with the manufacturer and the DNV Medical Device Certification portal.If you are looking to verify a specific medical device, tell me the exact product name or the certificate number so I can help you check its validity.
Read more about our services for medical devices here and EX equipment here.
Manufacturers face increasing challenges to satisfy customer and certification requirements. In both Europe and the US, manufacturers experience that review processes are becoming more complicated and less predictable. Some countries have more comprehensive rules than others. Presafe understands that time to market and the ability to manage increasingly complex regulatory requirements are key concerns for manufacturers today.
That's why we emphasize that Presafe builds its services on trust, credibility and a long-standing industry position. Tougher safety and quality standards mean tougher requirements on those who test and assess. At Presafe, we pride ourselves in an uncompromising approach towards ensuring the safety and performance in our customers´ products and systems.
We work closely with our customers to properly understand their business needs, always searching for the optimal certification solutions. Presafe has resources in all major markets with expertise in standards and regulations in the local language as well as in English, able to deliver according to your certification needs.
With Presafe, you can enjoy an extensive reach and service offering, reduced time to market, and foremost, a trusted partner!
