CE Certificates and Declarations of Conformity for dental products should not be considered expired solely by reference to the date initially stated on the documents. For certain medical devices previously certified in accordance with MDD – Directive 93/42/EEC, European legislation provides for a transition period to the new legislative framework MDR – Regulation (EU) 2017/745.

This transition period was extended by Regulation (EU) 2023/607, so that certain certificates issued under the MDD may continue to have effect even after their initial expiry date, until the transitional deadlines provided for by the applicable legislation, provided that the legal requirements are met.

In these cases, the Extension Letter issued in connection with the certificate confirms that the respective devices benefit from the transition period and that MDD certification continues to be recognised during the process of transitioning to MDR.

Therefore, the existence of an initial expiry date on the CE certificate or related documentation does not automatically mean that the product is no longer compliant. Validity must be assessed together with the Extension Letter, the device’s status during the MDD–MDR transition period, and the provisions of Regulation (EU) 2023/607.

The purpose of this transition period is to allow manufacturers to complete the MDR certification process without unjustified interruption of the placing on the market of devices that meet the transitional conditions provided for by European legislation.

ANMDMR Operating Notice

ANMDMR Notice

EUDAMED

Importer, RO-IM-000003641, S.C. Dental Equipment Store S.R.L [Romania]

COXO

• CE MDD Certificate
• CE MDR Certificate
• Turbines: Declaration of Conformity
• Lupe: Declaration of Conformity
• Contra-angle pieces, straight pieces, micromotors: Declaration of Conformity
• Microscopes: Declaration of Conformity
• C-Sailor, C-Sailor+ Physiodispensers: Declaration of Conformity
• C-Sailor Pro+, C-Sailor S1, C-Sailor Air Physiodispensers: Declaration of Conformity
• Torque Wrench C-TW1: Declaration of Conformity
• C-Smart-I Pilot and C-Smart-Mini AP endomotors: Declaration of Conformity
• C-Smart-Mini AP+ Endomotor: Declaration of Conformity
• C-Smart Endomotor:Declaration of Conformity
• Gutta Cutter C-Blade: Declaration of Conformity
• Apex Locator: Declaration of Conformity
• Vitality Tester C-Pulse: Declaration of Conformity
• Microsablator CA-1: Declaration of Conformity
• C-Puma Electric Micromotors: Declaration of Conformity
• C-Puma EX Electric Micromotor: Declaration of Conformity
• C-Puma PRO Electric Micromotor: Declaration of Conformity
• C-Puma MASTER Electric Micromotor: Declaration of Conformity
• C-Fill Mini G Type Gutta-Percha Obturation System: Declaration of Conformity
• C-Fill Mini P Type Gutta-Percha Obturation System: Declaration of Conformity
• CFR-1 and CFR-2 Fractured Instrument Removal Systems: Declaration of Conformity
• Photo Lamps: Declaration of Conformity
• Scialytic Lamps: Declaration of Conformity
• Whitening Lamp C-Bright: Declaration of Conformity
• 2-in-1 Prophylaxis Device PT-Master: Declaration of Conformity
• Piezotom C-EXPLORER: Declaration of Conformity
• TP-1 Prophylaxis Polisher: Declaration of Conformity
• Endo Ultra Smart AI Ultrasonic Activator: Declaration of Conformity
• UA-1 Implant Activator: Declaration of Conformity
• DL-300P Intraoral Scanner: Declaration of Conformity

WOSON

• CE Certificate
• CE Certificate Extension
• Water Distiller Woson Drink 10: Declaration of Conformity
• Bag Sealer Selin Woson: Declaration of Conformity
• Autoclave Woson Tanda Steri 23L: Declaration of Conformity
• Autoclave Woson Tanzo Touch 23L: Declaration of Conformity
• Woson Tanda PRO 23L Autoclave: Declaration of Conformity
• Woson Tancy 2L Autoclave: Declaration of Conformity
• Woson Tanco 8L Autoclave: Declaration of Conformity

JOIDENT

• CE Certificate
• Autoclave Joident Novo PRO 23L: Declaration of Conformity
• Sealer Joident: Declaration of Conformity
• Water Distiller Joident: Declaration of Conformity

ANLE

• CE Certificate
• CE Certificate Extension
• Dental Unit Anle: Declaration of Conformity

GREELOY

• CE Certificate
• Compressor Greeloy: Declaration of Conformity
• Pumps Greeloy: Declaration of Conformity

MORITA

• • CE Certificate
  • Root ZX MINI: Declaration of Conformity
  • Dentaport: Declaration of Conformity
  • ZX2: Declaration of Conformity
  • ZX2+: Declaration of Conformity

Fomos

• CE Certificate
• CE extension Letter: Declaration of Conformity
• Fomos 22L Class B Autoclave:Declaration of Conformity
• Fomos Sealer:Declaration of Conformity
• Fomos Water Distiller:Declaration of Conformity

METASYS

• CE Certificate
• User Manual