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SOL-M Tube Holder with Luer Lock Adapter - EUDAMED Registration 00818392018158

Access comprehensive regulatory information for SOL-M Tube Holder with Luer Lock Adapter 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 00818392018158 and manufactured by Sol-Millennium Medical, Inc. in United States.

This page provides complete registration details including trade name (SOL-M Tube Holder with Luer Lock Adapter), 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 I
00818392018158
No
SOL-M Tube Holder with Luer Lock Adapter
Trade Name: SOL-M Tube Holder with Luer Lock Adapter
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Device Description (EMDN)

HOLDERS FOR COLLECTION NEEDLES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
A01018001
Trade Name
SOL-M Tube Holder with Luer Lock Adapter
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00818392018158
Basic UDI
B-00818392018158
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
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Poland
Market Available
France:None~None, Latvia:None~None, Netherlands:None~None, Poland:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No