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Kids-e-Dental LLP receives EU MDR quality management system certificate and ISO 13485:2016 certificate

Kids-e-Dental LLP (60% held jointly controlled entity) received EU MDR quality certificate from TÜV SÜD.

By ScoutQuest · Wed 4 Nov 2026, 9:46 PM IST · 2 min read

EU MDR Certificate

Class IIa; valid Nov 4, 2026 to Nov 3, 2031

ISO 13485:2016 Validity

valid till Nov 3, 2029

Entity Holding

Kids-e-Dental LLP (60% held jointly controlled entity)

What was announced

• On November 4, 2026, Kids-e-Dental LLP (KED), a jointly controlled entity in which Laxmi Dental Limited holds 60% interest, received certificates issued by TÜV SÜD Product Service GmbH, Munich, Germany, a Notified Body with identification no. 0123.

EU Quality Management System Certificate

• Issued under Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapter I.
• As stated in the certificate, KED's quality management system was evaluated against this regulation with a positive result.
• Classification: Class IIa.
• Device group: MDN 1103 - Non-active dental implants and dental materials.
• Valid from November 4, 2026 until November 3, 2031.

Devices covered

• A Confirmation Statement on the devices covered by the EU certificate is valid only in combination with the certificate.
• Devices confirmed: E-iodocal, E-MTA Putty, E-MTA, E-MTA Sealer, Bioflx crown, Kids-e-crown and Kids-e-SSC.

ISO certificate

• Certificate under ISO 13485:2016 (EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021) - Medical devices - Quality management systems - Requirements for regulatory purposes.
• Scope: Design, Development, Manufacture & Distribution of Non-Implantable and Implantable Dental Products such as Preformed Crowns, Orthodontic Appliances, Dental Cements, Endodontic Appliances and Instruments.
• Valid from November 4, 2026 until November 3, 2029.

What it means

• Per the update, the EU MDR certification enables KED, upon completion of the applicable regulatory formalities, to market these devices in the European Union and the European Economic Area.
• All the certificates were issued on November 4, 2026 and are subject to periodical surveillance by TÜV SÜD.

How to read this

• This is a regulatory and market-access step for a majority-held, jointly controlled entity. It is an eligibility certification, distinct from any order, contract or sales figure.
• The commercial benefit depends on actual sales of the covered products in the EU/EEA once the remaining formalities are completed.
• The ISO certificate covers the design, development, manufacture and distribution of a range of dental products, and runs for a shorter period than the EU certificate, so renewal timelines differ.

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