17.06.2025
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 or make available on the Romanian market medical devices of type ‘Clinical Electronic Thermometers – Infrared Ear/Forehead Thermometers – Infrared Ear Thermometers – Infrared Forehead Thermometers – Nerve and Muscle Stimulators – Electrical Acupuncture Stimulators – Transcutaneous Electrical Nerve Stimulators – Electrical Muscle Stimulators – Electrical Neuromuscular Incontinence Stimulators – Ultrasound Physical Therapy Devices – Ultrasound and Electrical Neuromuscular Stimulators – Magnetic Stimulators – Electromagnetic Stimulators – Stimulation Electrodes – Electromyograph (EMG) Biofeedback Device – Electromyograph (EMG) Biofeedback and Neuromuscular Stimulator – Shortwave Therapy Devices – Laser Therapy Devices’ accompanied by a falsified copy of CE certificate of conformity no. HD 60147882 0001, which would have been issued by Notified Body TÜV Rheinland LGA Products GmbH (0197) on 2021-06-03 and valid until 2025-06-21.
The valid EC Certificate of Conformity with No. HD 60147882 0001 HD 60147882 0001 was issued by Notified Body TÜV Rheinland LGA Products GmbH (0197) on 2020-08-03, valid until 2024-05-26, for the same product categories, belonged to manufacturer Shenzhen Dongdixin Technology Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ‘Clinical Electronic Thermometers – Infrared Ear/Forehead Thermometers – Infrared Ear Thermometers – Infrared Forehead Thermometers – Nerve and Muscle Stimulators – Electrical Acupuncture Stimulators – Transcutaneous Electrical Nerve Stimulators – Electrical Muscle Stimulators – Electrical Neuromuscular Incontinence Stimulators – Ultrasound Physical Therapy Devices – Ultrasound and Electrical Neuromuscular Stimulators – Magnetic Stimulators – Electromagnetic Stimulators – Stimulation Electrodes – Electromyograph (EMG) Biofeedback Device – Electromyograph (EMG) Biofeedback and Neuromuscular Stimulator – Shortwave Therapy Devices – Laser Therapy Devices’ based on the falsified copy of CE certificate of conformity no. HD 60147882 0001 HD 60147882 0001, do not use them 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.
National Agency for Medicines and Medical Devices of Romania
