0543
Presafe Denmark A/S
Designations
Conformity assessment annexesAnnex VI, Annex II, Annex V, Annex III, Annex IV
Designated since2006-04-09
Full scope text from the register
Annexes
- Annex VI, Annex II, Annex V, Annex III, Annex IV
Procedures
- Full quality assurance system, Production quality assurance, EC type-examination, EC verification, Product quality assurance
Products
- dental materials
- heart-lung machines
- single use products for heart-lung machines
- infusion devices
- contact lenses
- radiotherapy equipment
- stimulation equipment
- Non-active medical devices
- equipment for measuring blood and anaesthesic gas
- suction equipment
- Active medical devices
- electrocardiographs and electroencephalographs
- surgical lasers
- Diagnostic X-ray equipment
- contact lens fluids
- radiotherapy planning software
- condoms and contraceptive pessaries
- surgical articles
- defibrillators
- dental devices
- electrosurgical equipment
- hearing aids and audiometers
- surgical implants (non-orthopaedic implants and bone cement)
- drains, probes and suction devices
- bandages and dressings
- sutures and adhesives
- ultrasound equipment
- CT-scanner
- medical equipment sterilizers
- dental implants
- intrauterine contraceptives
- patient-monitoring equipment and equipment for recording vital functions
- neonatal equipment
- disinfection means
- cardiovascular implants
Source: EU Single Market Compliance Space (SMCS), retrieved 2026-06-23.
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=0543
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=0543
This page is an informational mirror of the official register. It is not affiliated with the European Commission. Always verify the current designation and scope against the official SMCS record before relying on it.