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Plak Smacker Relief Wax - Mint Scented (144 ct) - EUDAMED Registration 10843471137588

Access comprehensive regulatory information for Plak Smacker Relief Wax - Mint Scented (144 ct) 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 10843471137588 and manufactured by Young Innovations Inc in United States.

This page provides complete registration details including trade name (Plak Smacker Relief Wax - Mint Scented (144 ct)), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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
10843471137588
No
Plak Smacker Relief Wax - Mint Scented (144 ct)
Trade Name: Plak Smacker Relief Wax - Mint Scented (144 ct)
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Device Description (EMDN)

DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q019003
Trade Name
Plak Smacker Relief Wax - Mint Scented (144 ct)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
10843471137588
Basic UDI
0843471145251EGDD409984NG
Version Date
February 21, 2025
Manufacturer Last Update
May 10, 2023
Active Status
No
Manufacturer
Manufacturer Name
Young Innovations Inc
Country
United States
Country Type
NON_EU
Address
2260 Wendt Street Algonquin
Email
info@ydnt.com
Authorized Representative
SRN
IE-AR-000011249
Country
Ireland
Address
Clogherane Dungarven, County Waterford
Email
YMBI@younginnovations.com
Telephone
+ 35 3 584 59 66
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No