08.11.2023
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 or make available on the Romanian market: Spacer for aerosol manufactured by Ningbo Foyomed Medical Instruments Co., Ltd., China, if they have come into possession of the falsified copy of CE certificate of conformity no. G2 093011 0006 Rev.01 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 2019-11-26, valid until 2024-05-26 for this manufacturer, copy which includes this medical device as well.
The valid certificate, issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) for manufacturer Ningbo Foyomed Medical Instruments Co., Ltd., China has the same identification data, namely number, issue and expiry date and covers only the following product categories: Sterile Nonactive Medical Devices and Active Medical Devices – Endotracheal Tube, Reinforced Endotracheal Tube, Latex Foley Catheter, Urethral Catheters(PVC), Nelaton Catheters(latex), Laryngeal Mask Airways, Tracheostomy Masks, Oxygen Masks, Nebulizers Masks, Venturi Masks, Oxygen Masks With Reservoir Bag, Connecting Tubes With Yankauer Handle, Oxygen Connection Tubings, Nasal Oxygen Cannula, Safety Syringes, Auto Disable Syringes, Disposable Syringes, Disposable Hypodermic Needles, Safety Disable Syringe, Sterile Infusion Sets for Single Use, Sterile Transfusion Sets for Single Use, Sterile Scalp Vein Type Needles for Single Use, Three-way Stopcocks(with Extension Tube), Heparin Caps, I.V. Cannula for Single Use, Insulin Needles for Single Use, Disposable Scalpel With Plastic Handle, Blood Lancet, Sterile Surgical Blade, Gauze Balls, Non-woven Balls(with X-ray), Lap Sponges, Oropharyngeal Airway, Resuscitation Mask, Silicone/SEBS/PVC Manual Resuscitators, Wound Drainage Reservoir, Sterile Latex Surgical Gloves, Digital Thermometers, Digital Blood Pressure Monitors, Electronic Sphygmomanometers, Disposable Irrigating and Feeding Syringes, Disposable Cervical Brushes.
We hereby draw the attention of interested parties that, according to the information held by the NAMMDR, in addition to the falsified copy of the above-mentioned certificate, for this manufacturer there is also a forged copy of certificate no. Q6 093011 0010 Rev. 00 which would have been issued by Certifying Body TÜV SÜD Product Service GmbH, Germany on 2022-07-06 valid until 2025-01-26 in accordance with the requirements of standard EN ISO 13485:2016 – Quality management systems. Requirements for regulatory purposes for Production and Distribution of Medical Devices – Endotracheal Tube, Reinforced Endotracheal Tube, Latex Foley Catheter, Urethral Catheters (PVC), Nelaton Catheters (latex), Sterile Feeding Tubes, Disposable Rectal Tubes, Sterile Suction Catheters, Disposable Stomach Tubes, Disposable Mucus Extractors, Disposable Umbilical Cord Clamps, Disposable I.D. Bracelets, Laryngeal Masks Airways, Tracheostomy Masks, Oxygen Masks, Nebulizers Masks, Venturi Masks, Oxygen Masks with Reservoir Bag, Connecting Tubes with Yankauer Handle, Oxygen Connection Tubings, Nasal Oxygen Cannula, Safety Syringes, Auto Disable Syringes, Disposable Syringe, Disposable Hypodermic Needles, Safety Disable Syringes, Sterile Infusion Sets for Single Use, Sterile Transfusion Sets for Single Use, Sterile Scalp Vein Type Needles for Single Use, Disposable Irrigating and Feeding Syringes, Three-way Stopcocks (with Extension Tube), Heparin Caps, I.V. Cannula for Single Use, Insulin Needles for Single Use, Disposable Scalpel with Plastic Handle, Blood Lancet, Sterile Surgical Blade, Gauze Rolls, Gauze Bandages, Gauze Sponges, Alcohol Pad, CPR Mask, Gauze Balls, Non-woven Balls (with X-ray), Lap Sponges, Cotton Tipped Applicators, Absorbent Cotton Balls, Medical Dressing Kits, Dressing Eye Pads, Absorbent Cotton Wools, Surgical Brushes, Oropharyngeal Airway, Resuscitation Mask, Silicone/SEBS/PVC Manual Resuscitators, Wound Drainage Reservoir, Urine Bag, Swab, Disposable Cervical Brushes, Sterile Examination Gloves, Sterile Latex Surgical Gloves, Surgical Gowns, Digital Thermometers, Digital Blood Pressure Monitors, Electronic Sphygmomanometers, Medical Bandages, Adhesive Dressing Series, Non-woven Gowns, Non-woven Face Mask, Non-woven Caps, Non-woven Shoe Cover, PE Aprons, Stethoscope, ECG Electrode, TENS Electrode, Wheel Chairs, Walking Aids, Operating Tables, Operating Lamps, Oxygen Concentrators, Vaginal Speculum, Disposable Surgical Drape, Adult Diaper, Silicone Condom Catheter, Wooden Tongue Depressors, Frozen Ice Pack, Mattresses, Ear/Ulcer Syringe, Single-use Medical Packing for Sterilized Medical Devices, Spacer for aerosol.
If you have come into possession of such medical devices of type Spacer for aerosol for which you were shown a falsified copy of the Certificate of Conformity no. G2 093011 0006 Rev.01 or of certificate no. Q6 093011 0010 Rev. 00 , 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.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate
National Agency for Medicines and Medical Devices of Romania
