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Dental Irrigation Syringes - EUDAMED Registration 06973158630099

Access comprehensive regulatory information for Dental Irrigation Syringes 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 06973158630099 and manufactured by iBrite Suzhou Technology Co., Ltd in China.

This page provides complete registration details including trade name (Dental Irrigation Syringes), manufacturer information, authorized representative details, competent authority (DE/CA38 - Regierungspräsidium Karlsruhe), 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 I
06973158630099
No
Dental Irrigation Syringes
Trade Name: Dental Irrigation Syringes
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Device Description (EMDN)

INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
A020102010102
Trade Name
Dental Irrigation Syringes
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06973158630099
Basic UDI
697315863LLEISS0000183
Version Date
November 08, 2023
Manufacturer Last Update
March 28, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 51 Zhousidun road Suzhou City (Jiangsu Province )
Email
ellen.li@pac-dent.com.cn
Authorized Representative
SRN
DE-AR-000009077
Country
Germany
Address
34/2 Obere Seegasse Heidelberg
Email
info@llins-service.com
Regulatory Information
Competent Authority
DE/CA38 - Regierungspräsidium Karlsruhe
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:2020-01-01~2023-11-17
Device Characteristics
Human Tissues
No
Animal Tissues
No