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EUDAMED registration 08800263100224No

Dental Surgical Instrument

Neobiotech Co.,Ltd.Class IEU EUDAMEDTrade name: Aqua System
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
P01020180
Trade name
Aqua System
Implantable
No
Reusable
Yes
Measuring function
No
Registration information
Primary DI
08800263100224
Basic UDI
880927676NBRSIRSCL1S03FT
Version date
December 27, 2024
Manufacturer last update
August 20, 2024
Active status
No
Manufacturer
Manufacturer name
Neobiotech Co.,Ltd.
Country
Republic of Korea
Country type
NON_EU
Address
70, Sinpyeong-ro, Jijeong-myeon Wonju-si, Gangwon-do
Email
ysdong@neobiotech.com
Authorized representative
Name
AR Experts B.V.
SRN
NL-AR-000023989
Country
Netherlands
Address
7 Amerlandseweg Breukelen
Email
info@ar-experts.eu
Telephone
+31889951333
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Poland
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

DENTAL IMPLANTS - ACCESSORIES

About this record

Access comprehensive regulatory information for Dental Surgical Instrument in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 08800263100224 and manufactured by Neobiotech Co.,Ltd. in Republic of Korea.

This page provides complete registration details including trade name (Aqua System), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.