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Manual Dental Scaler, Reusable - EUDAMED Registration 00841013120299

Access comprehensive regulatory information for Manual Dental Scaler, Reusable 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 00841013120299 and manufactured by American Eagle Instruments in United States.

This page provides complete registration details including trade name (SCALER 204S XP (3/8) YELLOW), 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
00841013120299
No
Manual Dental Scaler, Reusable
Trade Name: SCALER 204S XP (3/8) YELLOW
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Device Description (EMDN)

SURGICAL DENTAL DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010399
Trade Name
SCALER 204S XP (3/8) YELLOW
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
00841013120299
Basic UDI
0841013135320EMND1696817Q
Version Date
January 23, 2025
Manufacturer Last Update
May 08, 2023
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
6575 Butler Creek Road Missoula
Email
customerservice@younginnovations.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