24.09.2021
To the attention of all importers and distributors of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type Disposable Anesthetic Breathing Circuits, Disposable Heat and Moisture Exchanger Filters, Disposable Tracheal Tubes, Disposable Oxygen Masks, Disposable Anesthetic Masks, Laryngeal Mask Airway, Disposable Manual Resuscitators, Disposable Heparin Cap, Disposable Suction Catheters, Disposable Three Way Stopcock, Latex Foley Catheters, Laryngoscope Blades, Wound Drainage System, Tracheostomy Tubes, Nelaton Catheters, Stomach Tubes, All Silicone Stomach Tubes, Feeding Tubes, Reinforced Endotracheal Tubes, Bacteria/Viral Filters, Humidifier, Chest Drainage Bottle, Condom Catheters, Disposable Venturi Masks, Disposable Venturi Masks, Disposable Nebulizer Masks, Disposable Oxygen Masks with Reservoir Bags Nasal Oxygen Cannula, Disposable Syringe, Infusion Sets, Blood Transfusion Sets, Insulin Syringes, Hypodermic Needles, Blood Lancets, Extension Tubes, Disposable IV Catheters, Surgical Gloves, Surgical Suture, Digital Thermometers, Paraffin Gauze, Closed Suction System, Infusion Sets With Burette, Bubble Tubes, Connecting Tubes with Yankauer Handle, Spinal Needles, Tracheostomy Mask, Nebulizer Device, Electronic Sphygmomanometer, Infrared Thermometer, Fingertip Pulse Oximete, Disposable Electrosurgical Pencil; Rectal Tubes, Disposable Umbilical Cord Clamps, Surgical Brush, Disposable I.D. Bracelets, Disposable Air Ways, Disposable Urine Bag, Alcohol Swabs, Gauze Swabs, Gauze Bandage, Swabs, Non-woven Field, Apron, Medical Bandage, Suction Liner; Aneroid Sphygmomanometers manufactured by Ningbo Sintrue Medical Instruments Co., Ltd., China, if they have received the falsified EC certificate of conformity no. DD 60104785 0001 which would have been issued by Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197) on 2019-12-11, valid until 2022-11-26.
Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the website of the National Agency for Medicines and Medical Devices of Romania, section IMPORTANT NOTIFICATIONS – MEDICAL DEVICES:
04.09.2020
To the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)
To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95/2006 on healthcare reform, republished, as further amended and supplemented.