TWiNY
- Risk class
- Class IIa
- CND nomenclatures code
- Q010299
- Trade name
- TWiNY Opaque Special InO 2 2.0ml
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 04560231202216
- Basic UDI
- 456023117D10B100N002U7
- Active status
- No
- Manufacturer name
- YAMAKIN CO., LTD.
- Country
- Japan
- Country type
- NON_EU
- Address
- 1090-3, Otani, Kamibun, Kochi
- contact@yamakin-gold.co.jp
- 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
- Italy
- Market available
- Bulgaria:None~None, Czechia:None~None, France:None~None, Greece:None~None, Italy:None~None, Latvia:None~None, Poland:None~None, Romania:None~None, Slovakia:None~None, Spain:None~None, United Kingdom (Northern Ireland only):None~None
- Human tissues
- No
- Animal tissues
- No
PROSTHETIC DENTISTRY DEVICES - OTHER
Access comprehensive regulatory information for TWiNY in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 04560231202216 and manufactured by YAMAKIN CO., LTD. in Japan.
This page provides complete registration details including trade name (TWiNY Opaque Special InO 2 2.0ml), 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.