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EUDAMED registration 06975718056288No

Dental Root Canal Instruments

Shenzhen Denco Medical Co., Ltd.Class IIaEU EUDAMEDTrade name: Limas Z-Glider EVO de Zarc
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Q010507
Trade name
Limas Z-Glider EVO de Zarc
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06975718056288
Basic UDI
B-06975718056288
Version date
September 20, 2024
Manufacturer last update
August 12, 2024
Active status
No
Manufacturer
Manufacturer name
Shenzhen Denco Medical Co., Ltd.
Country
China
Country type
NON_EU
Address
Room 3108, Block 6, Tian'an Cloud Park , Bantian street, Longgang District, Shenzhen, 518129，Guangdong P.R.China 518129 Shenzhen
Email
admin@chinacodent.com
Authorized representative
Name
Share info GmbH
SRN
DE-AR-000005132
Country
Germany
Address
83 Heerdter Lohweg Düsseldorf
Email
eu-rep@share-info.com
Regulatory information
Competent authority
The Medicines and Healthcare Products Regulatory Agency
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Spain
Market available
Spain:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE

About this record

Access comprehensive regulatory information for Dental Root Canal Instruments 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 06975718056288 and manufactured by Shenzhen Denco Medical Co., Ltd. in China.

This page provides complete registration details including trade name (Limas Z-Glider EVO de Zarc), manufacturer information, authorized representative details, competent authority (The Medicines and Healthcare Products Regulatory Agency), 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.