Sanatmetal
Impianti ortopedici, traumatologici e spinali e strumenti chirurgici.
Sanatmetal produce impianti ortopedici, traumatologici e della colonna vertebrale e strumenti chirurgici dalla sua base di Eger. L'azienda fornisce clienti al dettaglio, all'ingrosso, industriali ed esportatori nei suoi mercati primari quotati.
- Type
- Manufacturer
- Location
- Eger, Hungary
- Founded
- 1967
- Website
- sanatmetal.com
- Categories
- Forniture medicali e sanitarie, Utensili e attrezzature
- Markets
- Ungheria, Germania, Stati Uniti, Polonia
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission