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14,962 results

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Urgent Field Safety Notice for ACUVUE Vita Brand Diagnostic Lenses by Johnson & Johnson Vision Care PDF, 172KB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - contact lenses
Reference 08745/21

Urgent Field Safety Notice for ExacTrac Dynamic by Brainlab AG PDF, 355KB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 15831/20

Urgent Field Safety Notice for Injizierbare Hyaluronprodukte (für Gelenke) by Anika Therapeutics S.r.l. PDF, 558KB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 07218/21

Urgent Field Safety Notice for Neo Delta self safe 2 17G 45mm by Delta Med spa PDF, 2MB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 09011/21

Urgent Field Safety Notice for Kangaroo Enteral Feeding No.-Sterile Pump Sets by Covidien llc PDF, 177KB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 04351/21

Urgent Field Safety Notice for HydraSense Advanced by Penta Arzneimittel GmbH PDF, 692KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - liquid media for ophthalmological purposes
Reference 09070/21

Urgent Field Safety Notice for Video Mediastinoscope by Karl Storz S. & Co KG PDF, 381KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 08998/21

Urgent Field Safety Notice for Kontaktlinsenpflegemittel by Bausch & Lomb Inc PDF, 452KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - contact lenses
Reference 08450/21

Urgent Field Safety Notice for Zimmer Natural Nail Cephalomedullary Nail by Zimmer Switzerland Manufacturing GmbH PDF, 168KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08799/21

Urgent Field Safety Notice for Shark CP, cervical screw by Bricon GmbH PDF, 243KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08859/21

Urgent Field Safety Notice for LeMaitre Aortic Occlusion Catheter by LeMaitre Vascular, Inc. PDF, 83KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 09555/21

Urgent Field Safety Notice for MEXSOL by MEDITES PHARMA, spol. s r.o PDF, 135KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 09488/21

Urgent Field Safety Notice for syngo.via by Siemens Healthcare GmbH, SYNGO (SY) PDF, 423KB, File does not meet accessibility standards Date: 17. May 2021 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 09164/21

Urgent Field Safety Notice for Laryngeal Electrodes, Urethral Electrodes, Disposable needle electrodes for EEG and EMG, Disposable Stimulation Probes by SPES Medica Srl PDF, 139KB, File does not meet accessibility standards Date: 17. May 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 09046/21

How can I check and prove the validity of a certificate? Date: 14. May 2021 Topics: Medical devices Type: FAQ

Some notified bodies provide "certificate databases" on their websites for general search. Please check the certificates yourself in the public database of the notified body that issued it.

If that is not sufficient, please directly contact the …

Do importers have to notify the registration of a medical device that is already registered in a member state of the European Economic Area to the German authorities? Date: 14. May 2021 Topics: Medical devices Type: FAQ

No, it is not necessary to register products in Germany that are already registered in a member state of the European Economic Area. European importers or authorized representatives based outside of Germany do not have to notify in the German Medical …

What are the registration obligations of importers according to MDR and IVDR? Date: 14. May 2021 Topics: Medical devices Type: FAQ

Please refer to Article 13 of Regulation (EU) 2017/745 for the general obligations of importers under the MDR (effective date 5/26/2021). The effective date of the IVDR is 5/26/2022.
Under the new MDR and IVDR regulations, there is an obligation for …

What are the registration obligations of importers according to the transitional provisions of § 96 MPDG in reference to the Medical Devices Act (MPG)? Date: 14. May 2021 Topics: Medical devices Type: FAQ

There is a possibility of registering "importers" in the sense of the German Medical Devices Act (MPG), however, we want to point out the definition in § 5 MPG. It is stated there that the importer is the responsible person if medical devices are not …

Can BfArM validate the authenticity of certificates for medical devices? Date: 14. May 2021 Topics: Medical devices Type: FAQ

No, BfArM cannot provide any information on the authenticity or validity of certificates.

Urgent Field Safety Notice for Innova IGS systems by GE Medical Systems SCS PDF, 297KB, File does not meet accessibility standards Date: 12. May 2021 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 08909/21