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Injectable Dermal Filler - EUDAMED Registration 08800047403428

Access comprehensive regulatory information for Injectable Dermal Filler in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 08800047403428 and manufactured by SCL Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (Injectable Dermal Filler), 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 III
08800047403428
No
Injectable Dermal Filler
Trade Name: Injectable Dermal Filler
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Device Description (EMDN)

PLASTIC SURGERY AND NON-AESTHETIC PURPOSES GENERIC USE INSTRUMENTS AND KITS, SINGLE-USE

Device Classification
Risk Class
Class III
CND Nomenclatures Code
V901601
Trade Name
Injectable Dermal Filler
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800047403428
Basic UDI
B-08800047403428
Version Date
April 20, 2022
Manufacturer Last Update
June 18, 2021
Active Status
No
Manufacturer
Manufacturer Name
SCL Co., Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
186 Galmachi-ro Jungwon-gu, Sungnam-si, Gyeonggi-do
Email
sclmedical@naver.com
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:None~None, Netherlands:None~None, Sweden:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No