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Dale Scrape-n-Suction Tongue Cleaner - EUDAMED Registration 00817612021008

Access comprehensive regulatory information for Dale Scrape-n-Suction Tongue Cleaner 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 00817612021008 and manufactured by Dale Medical Products, Inc. in United States.

This page provides complete registration details including trade name (Dale Scrape-n-Suction Tongue Cleaner), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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
00817612021008
No
Dale Scrape-n-Suction Tongue Cleaner
Trade Name: Dale Scrape-n-Suction Tongue Cleaner
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Device Description (EMDN)

CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V80
Trade Name
Dale Scrape-n-Suction Tongue Cleaner
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00817612021008
Basic UDI
0817612022205V
Version Date
December 02, 2024
Manufacturer Last Update
January 17, 2022
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
40 Kenwood Circle 02038 Franklin
Email
r.gruneberg@dalemed.net
Authorized Representative
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No