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SOL-M Hypodermic Needle - EUDAMED Registration 00818392015102

Access comprehensive regulatory information for SOL-M Hypodermic 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 00818392015102 and manufactured by Sol-Millennium Medical, Inc. in United States.

This page provides complete registration details including trade name (SOL-M Hypodermic 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
00818392015102
No
SOL-M Hypodermic Needle
Trade Name: SOL-M Hypodermic Needle
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Device Description (EMDN)

HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
A0101010102
Trade Name
SOL-M Hypodermic Needle
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00818392015102
Basic UDI
081006243NDL1YE
Version Date
December 12, 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
Austria:None~None, Belgium:None~None, Croatia:None~None, Czechia:None~None, Denmark:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No