Sterile and non sterile reusable hand tools for root canal preparation during endodontic treatment
- Risk class
- Class I
- CND nomenclatures code
- L159004
- Trade name
- H-FILES
- Implantable
- No
- Reusable
- Yes
- Measuring function
- No
- Primary DI
- 07640142415152
- Basic UDI
- 7640142410301029G
- Active status
- No
- Manufacturer name
- FKG Dentaire Sàrl
- Country
- Switzerland
- Country type
- NON_EU
- Address
- 4 Le Crêt-du-Locle Le Crêt-du-Locle
- info@fkg.ch
- SRN
- NL-AR-000000116
- Country
- Netherlands
- Address
- 60 Westervoortsedijk Arnhem
- lst.aus.euauthrep@ul.com
- Telephone
- +31 70 345 8570
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Germany
- Market available
- Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
- Human tissues
- No
- Animal tissues
- No
ENDODONTIC RASPS AND FILES, REUSABLE
Access comprehensive regulatory information for Sterile and non sterile reusable hand tools for root canal preparation during endodontic treatment in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 07640142415152 and manufactured by FKG Dentaire Sàrl in Switzerland.
This page provides complete registration details including trade name (H-FILES), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.