09.02.2026
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 ‘Laryngeal Mask Airways, Stomach Tubes, Drainage Tubes, Endotracheal Tubes, Oxygen Masks, Suction Catheters, Nasal Oxygen Cannulas, Breathing Circuits, Heat and Moisture Exchangers, Breathing System Filters, Manual Resuscitators, Wound Drainage Systems, Infusion Sets with Precision Filters for Single-Use, Double Lumen Endobronchial Tubes, Single-Use Anesthesia Kits, Urinary Catheterization Collection Kits, Disposable Endobronchial Blocker Tubes, Anesthesia Masks, Catheter Mounts, Suction Tubing with Yankauer Handle, Nebulizer Masks, Tracheostomy Tubes’, accompanied by a falsified copy of CE certificate of conformity no. G2.086250.0018 Rev.01, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2022-01-06 and valid until 2027-05-26.
The valid CE Certificate of Conformity with No. G2.086250.0018 Rev.01 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2020-01-08, valid until 2024-05-26, for ‘Laryngeal Mask Airways, Stomach Tubes, Drainage Tubes, Endotracheal Tubes, Oxygen Masks, Suction Catheters, Nasal Oxygen Cannulas, Breathing Circuits, Heat and Moisture Exchangers, Breathing System Filters, Manual Resuscitators, Wound Drainage Systems, Infusion Sets with Precision Filters for Single-Use, Double Lumen Endobronchial Tubes, Single-Use Anesthesia Kits, Urinary Catheterization Collection Kits, Disposable Endobronchial Blocker Tubes, Anesthesia Masks, Catheter Mounts, Suction Tubing with Yankauer Handle, Nebulizer Masks, Tracheostomy Tubes’ and belongs to manufacturer Ningbo Luke Medical Devices Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Laryngeal Mask Airways, Stomach Tubes, Drainage Tubes, Endotracheal Tubes, Oxygen Masks, Suction Catheters, Nasal Oxygen Cannulas, Breathing
Circuits, Heat and Moisture Exchangers, Breathing System Filters, Manual Resuscitators, Wound Drainage Systems, Infusion Sets with Precision Filters for Single-Use, Double Lumen Endobronchial Tubes,
Single-Use Anesthesia Kits, Urinary Catheterization Collection Kits, Disposable Endobronchial Blocker Tubes, Anesthesia Masks, Catheter Mounts, Suction Tubing with Yankauer Handle, Nebulizer Masks,
Tracheostomy Tubes’ on the Romanian territory based on a falsified copy of certificate no. G2.086250.0018 Rev.01, 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 your own verification, we recommend that interested parties consult the information posted 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
