FOOT ORTHOSES
- Risk class
- Class I
- CND nomenclatures code
- Y061203
- Trade name
- Digicare Elastic Caps
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00840269509377
- Basic UDI
- 08402695CL1068N
- Version date
- October 18, 2024
- Manufacturer last update
- May 26, 2021
- Active status
- No
- Manufacturer name
- La Pointique Int´l Ltd.
- Country
- United States
- Country type
- NON_EU
- Address
- 701 Fifth Ave, Suite 4200 Seattle
- kellyho@lp-support.com
- SRN
- DE-AR-000000085
- Country
- Germany
- Address
- 7 Ernst-Heckel-Straße St. Ingbert
- ear@mt-procons.com
- Telephone
- +49 6894 581020
- Competent authority
- DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Netherlands
- Market available
- Croatia:None~None, Finland:None~None, Germany:None~None, Greece:None~None, Netherlands:None~None
- Human tissues
- No
- Animal tissues
- No
ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)
Access comprehensive regulatory information for FOOT ORTHOSES 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 00840269509377 and manufactured by La Pointique Int´l Ltd. in United States.
This page provides complete registration details including trade name (Digicare Elastic Caps), manufacturer information, authorized representative details, competent authority (DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz), 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.