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F SIZE F5 - EUDAMED Registration 08800171203871

Access comprehensive regulatory information for F SIZE F5 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 08800171203871 and manufactured by ACEONEDENT KOREA INDUSTRIAL CO. in Republic of Korea.

This page provides complete registration details including trade name (Aceonedent Korea Industrial Company), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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
08800171203871
No
F SIZE F5
Trade Name: Aceonedent Korea Industrial Company
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Device Description (EMDN)

ROOT CANAL FILLING DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q01010299
Trade Name
Aceonedent Korea Industrial Company
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800171203871
Basic UDI
B-08800171203871
Version Date
June 14, 2024
Manufacturer Last Update
March 21, 2024
Active Status
No
Manufacturer
Country
Republic of Korea
Country Type
NON_EU
Address
22 Samjak - ro Bucheon-si
Email
aceonedent@hanmail.net
Authorized Representative
SRN
DE-AR-000005875
Country
Germany
Address
16 Sachsenhausener Str. Schwalbach am Taunus
Email
info@javitech.de
Telephone
+49 176 7298 9240
Regulatory Information
Competent Authority
DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Germany:2021-02-03~None, Greece:2023-05-03~None
Device Characteristics
Human Tissues
No
Animal Tissues
No