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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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DENTIS CO., LTD — Manufacturer in South Korea

EUDAMED update: Jul 23, 2025

DC

DENTIS CO., LTD

South Korea

All roles followed

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Sources: EUDAMED

Legal information of DENTIS

Legal name: DENTIS CO., LTD
EU VAT number: Not applicable
EORI: XI077628279000
SRN (displayed role): KR-MF-000012523
EUDAMED status: Active· registered in 2021
Registered office: Seongseoseo-ro, Dalseo-gu, 99 42718 Daegu, South Korea

Contact details for DENTIS

Phone: +82 1899 2804
Email: star7942@dentis.co.kr
Website: http://www.dentis.co.kr
Address: 99, SEONGSEOSEO-RO, DALSEO-GU 42718 DAEGU SOUTH KOREA

Data export

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Competent authority for DENTIS

Nemzeti Népegészségügyi és Gyógyszerészeti Központ
HungaryContact the authority →

Certificates of DENTIS

935Total Devices

17Basic UDI-DIs

1Certificates1 valid · 0 expiring < 12 months

3CountriesEU/EEA placements

Market presence of DENTIS

Devices placed in 3 countries

Spain830
Poland99
Germany6

Risk categories of DENTIS

Executives & regulatory representatives of DENTIS

4 contacts identified

KIM Byoung-soo
PRRC
View profile →
SHIN In-Sik
PRRC
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KIM Byoung-soo
- the technical documentation and the EU DoC are drawn up and kept up-to-date - the PMS obligations are complied with in accordance with Article 10(10) - the reporting obligations referred to in Articles 87 to 91 are fulfilled - in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued
Hidden
SHIN In-Sik
- the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released - the PMS obligations are complied with in accordance with Article 10(10) - the reporting obligations referred to in Articles 87 to 91 are fulfilled
Hidden

Related documents of DENTIS

Quality management system

Certificate IT353035Rev. 1

Issued

Manufacturer

DENTIS CO., LTD

Notified body

BUREAU VERITAS ITALIA S.P.A.

1370

Version

1

Valid from

5/26/2026

Valid until

5/25/2031

Catalog of DENTIS

935 devices · 17 families

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Surgical LuminaireS30010 versions
Surgical LuminaireL200, M210, M20015 versions
Surgical LuminaireL400, M40017 versions
DENTIS Implant Surgical Instrument System828 versions
Surgical LuminaireS2506 versions
Surgical LuminaireM310, M30010 versions
Surgical LuminaireS2009 versions
Dental LightC50010 versions
Dental LightC600, C70010 versions
Operating TableST500, ST500E, ST300, ST300E4 versions
Luminaire for diagnosisE1008 versions
DENOPS-i AI100 1 version
ChecQAC1001 version
Luvis Chair2 versions
Luvis ChairLC700C2 versions
s-Clean Tapered FixtureDSFM37081 version
s-Clean Tapered FixtureDSFM37101 version

Browse all 935 products

Cartography of DENTIS

Authorised representativeNotified bodiesPeople

BUREAU VERITAS ITALIA S.P.A. — 1 certificate — DENTIS
BEST FIT IMPLANTS S.A. — represents — DENTIS
KTR Europe GmbH — represents — DENTIS
KIM Byoung-soo — DENTIS
SHIN In-Sik — DENTIS