04-Nov-2026 21:47:34
LAXMI DENTAL : KIDS-E-DENTAL RECEIVES EU MDR AND ISO 13485 CERTIFICATES
• Kids-e-Dental LLP, a jointly controlled entity in which the company holds 60%, received certificates from TÜV SÜD (Notified Body 0123) on November 4, 2026 • EU Quality Management System Certificate under Regulation (EU) 2017/745, Class IIa, device group non-active dental implants and dental materials, valid November 4, 2026 to November 3, 2031 • Device confirmation covers E-iodocal, E-MTA Putty, E-MTA, E-MTA Sealer, Bioflx crown, Kids-e-crown and Kids-e-SSC • ISO 13485:2016 certificate valid November 4, 2026 to November 3, 2029 for design, development, manufacture and distribution of non-implantable and implantable dental products • EU MDR certification enables KED, upon completion of applicable regulatory formalities, to market these products in the European Union and European Economic Area • Certificates are subject to periodical surveillance by TÜV SÜD
Laxmi Dental Ltd
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