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EUDAMED registration ++E490HE21KLNZYes

Eco Line Turbine HE21KL

MK-dent GmbHClass IIaEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Q010199
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
++E490HE21KLNZ
Basic UDI
B-++E490HE21KLNZ
Version date
February 07, 2023
Manufacturer last update
August 17, 2021
Active status
Yes
Manufacturer
Manufacturer name
MK-dent GmbH
Country
Germany
Country type
EU_MEMBER_STATE
Address
2 Marie-Curie-Straße Bargteheide
Email
info@mk-dent.com
Regulatory information
Competent authority
DE/CA01 - Landesamt für soziale Dienste Schleswig-Holstein Abteilung 3 Gesundheits- und Verbraucherschutz
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Germany
Market available
Germany:1995-01-01~2023-02-07
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER

About this record

Access comprehensive regulatory information for Eco Line Turbine HE21KL in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI ++E490HE21KLNZ and manufactured by MK-dent GmbH in Germany.

This page provides complete registration details including manufacturer information, competent authority (DE/CA01 - Landesamt für soziale Dienste Schleswig-Holstein Abteilung 3 Gesundheits- und Verbraucherschutz), 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.