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Safety Syringe with fixed needle (Shield Technology) - EUDAMED Registration 00818392011869

Access comprehensive regulatory information for Safety Syringe with fixed needle (Shield Technology) 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 00818392011869 and manufactured by Sol-Millennium Medical, Inc. in United States.

This page provides complete registration details including trade name (SOL-GUARD TB Safety Syringe with Fixed Needle), manufacturer information, authorized representative details, competent authority (Urzฤ…d Rejestracji Produktรณw Leczniczych), 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
00818392011869
No
Safety Syringe with fixed needle (Shield Technology)
Trade Name: SOL-GUARD TB Safety Syringe with Fixed Needle
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Device Description (EMDN)

INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
A02010205
Trade Name
SOL-GUARD TB Safety Syringe with Fixed Needle
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
00818392011869
Basic UDI
081006243SSG13G
Version Date
November 22, 2024
Manufacturer Last Update
October 26, 2023
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
311 S Wacker Drive, Suite 4100 N/A Chicago
Email
EMEA_QRA@sol-m.com
Authorized Representative
SRN
PL-AR-000010397
Country
Poland
Address
18 Twarda N/A Warszawa
Email
EMEA_QRA@sol-m.com
Regulatory Information
Competent Authority
Urzฤ…d Rejestracji Produktรณw Leczniczych
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Market Available
Poland:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No