Pure Global

Oral Dispensing Syringe (Non-Sterile) - EUDAMED Registration 00840368504945

Access comprehensive regulatory information for Oral Dispensing Syringe (Non-Sterile) 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 00840368504945 and manufactured by Sol-Millennium Medical, Inc. in United States.

This page provides complete registration details including trade name (SOL-M 2x1ml Oral Dispensing Syringe Clear with 1 Bottle 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
00840368504945
No
Oral Dispensing Syringe (Non-Sterile)
Trade Name: SOL-M 2x1ml Oral Dispensing Syringe Clear with 1 Bottle Adapter
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

SYRINGES, SINGLE-USE - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
A020199
Trade Name
SOL-M 2x1ml Oral Dispensing Syringe Clear with 1 Bottle Adapter
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
00840368504945
Basic UDI
081006243ORL22Y
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