EUDAMED registration 00817612021008No

Dale Scrape-n-Suction Tongue Cleaner

Name: Dale Scrape-n-Suction Tongue Cleaner — EUDAMED registration 00817612021008
Creator: Dale Medical Products, Inc.
Keywords: Dale Scrape-n-Suction Tongue Cleaner, 00817612021008, Dale Scrape-n-Suction Tongue Cleaner, Class I, Dale Medical Products, Inc., EUDAMED registration

Dale Medical Products, Inc.Class IEU EUDAMEDTrade name: Dale Scrape-n-Suction Tongue Cleaner

VerifiedEUDAMED · official EU database

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

Manufacturer name: Dale Medical Products, Inc.
Country: United States
Country type: NON_EU
Address: 40 Kenwood Circle 02038 Franklin
Email: r.gruneberg@dalemed.net

Authorized representative

Name: MDSS GmbH
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

Device description (EMDN)

CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES

About this record

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.