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TWiNY - EUDAMED Registration 04560231202131

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 04560231202131 and manufactured by YAMAKIN CO., LTD. in Japan.

This page provides complete registration details including trade name (TWiNY Opaque OC4 2.0ml), manufacturer information, authorized representative details, competent authority (DE/CA70 - Landesamt fรผr 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.

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EUDAMED Official Data
Class IIa
04560231202131
No
TWiNY
Trade Name: TWiNY Opaque OC4 2.0ml
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Device Description (EMDN)

PROSTHETIC DENTISTRY DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010299
Trade Name
TWiNY Opaque OC4 2.0ml
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04560231202131
Basic UDI
456023117D10B100N002U7
Active Status
No
Manufacturer
Manufacturer Name
YAMAKIN CO., LTD.
Country
Japan
Country Type
NON_EU
Address
1090-3, Otani, Kamibun, Kochi
Email
contact@yamakin-gold.co.jp
Authorized Representative
SRN
DE-AR-000000085
Country
Germany
Address
7 Ernst-Heckel-StraรŸe St. Ingbert
Email
ear@mt-procons.com
Telephone
+49 6894 581020
Regulatory Information
Competent Authority
DE/CA70 - Landesamt fรผr 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
Device Characteristics
Human Tissues
No
Animal Tissues
No