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Sterile Syringes for Single Use - EUDAMED Registration 06945144711563

Access comprehensive regulatory information for Sterile Syringes for Single Use 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 06945144711563 and manufactured by CHANGZHOU SHUANGMA MEDICAL DEVICES CO.,LTD in China.

This page provides complete registration details including trade name (Sterile Syringes for Single Use), manufacturer information, authorized representative details, competent authority (Agencia Espaรฑola de Medicamentos y Productos Sanitarios), 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
06945144711563
No
Sterile Syringes for Single Use
Trade Name: Sterile Syringes for Single Use
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Device Description (EMDN)

INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
A020102020101
Trade Name
Sterile Syringes for Single Use
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06945144711563
Basic UDI
69451447001ZSQ7E
Version Date
May 29, 2024
Manufacturer Last Update
November 07, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
San He Kou Development Zone,Zhenglu,Tianning ,213115 Changzhou ,Jiangsu,China Changzhou
Email
wendee@shuangma-china.com
Authorized Representative
SRN
DE-AR-000009077
Country
Germany
Address
26 Heinigstrasse Ludwigshafen
Email
info@llins-service.com
Regulatory Information
Competent Authority
Agencia Espaรฑola de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Bulgaria:None~None, France:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Latvia:None~None, Lithuania:None~None, Netherlands:None~None, Poland:None~None, Romania:None~None, Spain:None~None, Sweden:None~None, Tรผrkiye:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No