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SOL-M Slip Tip Syringe with Exchangeable Needle - EUDAMED Registration 00818392012804

Access comprehensive regulatory information for SOL-M Slip Tip Syringe with Exchangeable Needle 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 00818392012804 and manufactured by Sol-Millennium Medical, Inc. in United States.

This page provides complete registration details including trade name (SOL-M Slip Tip Syringe with Exchangeable 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
00818392012804
No
SOL-M Slip Tip Syringe with Exchangeable Needle
Trade Name: SOL-M Slip Tip Syringe with Exchangeable Needle
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Device Description (EMDN)

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

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
A020102010201
Trade Name
SOL-M Slip Tip Syringe with Exchangeable Needle
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
00818392012804
Basic UDI
081006243SN31YT
Version Date
December 13, 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
Croatia:None~None, Czechia:None~None, France:None~None, Italy:None~None, Poland:None~None, Portugal:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No