07.08.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Oral Dispenser – 2ml, 3ml, 5ml, 6ml, 10ml, 12ml, 20ml, Rubber Dropper Assembly, Glass Dropper Assembly, Measuring Cups, Measuring Spoons, Pilfer Proof Caps, Child Resistance Caps (CRC), Flip Top Caps, Tablet Bottles, Silicon Rubber Teats, Eye Drop Bottles, Dry Syrup Bottles, Crew Caps, Adopter, Plastic Plug, Piles Applicators, PCO Caps, Baby Droppers Set, Tablet Applicators, Gel Applicators, Oral Dispenser (0.3ml, 0.5ml, 1ml) manufactured by Neelkanth Polymer Industries, India, if they have come into possession of the falsified CE certificate of conformity no. DGM 930 which would have been issued by Notified Body Presafe Denmark A/S, Denmark (0483), on 2020-10-07, valid until 2025-10-06 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Oral Dispenser – 2ml, 3ml, 5ml, 6ml, 10ml, 12ml, 20ml, Rubber Dropper Assembly, Glass Dropper Assembly, Measuring Cups, Measuring Spoons, Pilfer Proof Caps, Child Resistance Caps (CRC), Flip Top Caps, Tablet Bottles, Silicon Rubber Teats, Eye Drop Bottles, Dry Syrup Bottles, Crew Caps, Adopter, Plastic Plug, Piles Applicators, PCO Caps, Baby Droppers Set, Tablet Applicators, Gel Applicators, Oral Dispenser(0.3ml, 0.5ml, 1ml) from manufacturer Neelkanth Polymer Industries, India, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.