As the manufacturer of a Class I medical device in accordance with Regulation (EU) 2017/745 (MDR), Rocket Dental GmbH is legally obliged to operate a vigilance system.
We ask all users and patients to report serious incidents in connection with the medical device RING without delay to:
Postal address
Rocket Dental GmbH, Bahnhofstraße 24, 79798 Jestetten, Germany
Phone
+49 7745 7211
A serious incident within the meaning of Art. 2 No. 65 MDR is any incident that directly or indirectly led, might have led or might lead to any of the following consequences:
Users and patients also have the option of reporting serious incidents directly to the competent authority:
Federal higher authority
Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM)
(Federal Institute for Drugs and Medical Devices)
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, Germany
Competent state authority of Baden-Wuerttemberg
Regierungspraesidium Freiburg
Referat 25 – Aerztliche und pharmazeutische Angelegenheiten, Medizinprodukte
(Regional Council of Freiburg, Unit 25 – Medical and Pharmaceutical Affairs, Medical Devices)
Bissierstrasse 7
79114 Freiburg, Germany
We will promptly confirm receipt of your report, examine the facts and, where necessary, take the required measures. In the case of serious incidents, the report is made to the competent authorities in accordance with Art. 87 MDR within the statutory deadlines.
Data protection: your report data will be processed exclusively for the purpose of handling the safety report and fulfilling legal obligations. See our Privacy Policy.
An EU Declaration of Conformity in accordance with Art. 19 of Regulation (EU) 2017/745 (MDR) has been issued for the medical device RING. The product bears the CE marking and is placed on the market in accordance with the applicable requirements of the MDR.
Date of CE marking:
15 July 2026
Date of the Declaration of Conformity:
15 July 2026 (version 01
MDR classification:
Class I in accordance with Annex VIII, Rule 5 of Regulation (EU) 2017/745.
