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SOL-GUARD Safety Pull-button Blood Collection Set with Pre-attached Holder - EUDAMED Registration 00810018093082

Access comprehensive regulatory information for SOL-GUARD Safety Pull-button Blood Collection Set with Pre-attached Holder 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 00810018093082 and manufactured by Sol-Millennium Medical, Inc. in United States.

This page provides complete registration details including trade name (SOL-GUARD Safety Pull-button Blood Collection Set with Pre-attached Holder ), 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
00810018093082
No
SOL-GUARD Safety Pull-button Blood Collection Set with Pre-attached Holder
Trade Name: SOL-GUARD Safety Pull-button Blood Collection Set with Pre-attached Holder
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Device Description (EMDN)

BUTTERFLY NEEDLES, WITHย SAFETY SYSTEMS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
A01010201
Trade Name
SOL-GUARD Safety Pull-button Blood Collection Set with Pre-attached Holder
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00810018093082
Basic UDI
B-00810018093082
Version Date
January 10, 2025
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
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Poland
Market Available
Finland:None~None, France:None~None, Poland:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No