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EUDAMED registration 08809369092662No

Cross-linked Hyaluronate Acid Dermal Filler

BNC KOREA, Inc.Class IIIEU EUDAMEDTrade name: ELEGA
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class III
CND nomenclatures code
P900402
Trade name
ELEGA
Implantable
Yes
Reusable
No
Measuring function
No
Registration information
Primary DI
08809369092662
Basic UDI
B-08809369092662
Version date
August 31, 2022
Manufacturer last update
February 10, 2023
Active status
No
Manufacturer
Manufacturer name
BNC KOREA, Inc.
Country
Republic of Korea
Country type
NON_EU
Address
62 Seongseogongdan-ro 11-gil Dalseo-gu, Daegu
Email
sales@bnckorea.co.kr
Authorized representative
Name
JaviTech e.K.
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
Cyprus:None~None, Germany:None~None, Sweden:None~None, Turkey:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

RESORBABLE FILLING AND RECONSTRUCTION DEVICES

About this record

Access comprehensive regulatory information for Cross-linked Hyaluronate Acid 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 08809369092662 and manufactured by BNC KOREA, Inc. in Republic of Korea.

This page provides complete registration details including trade name (ELEGA), 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.