CE mark and MDR
Tasso+ is a Class IIa medical device under Regulation (EU) 2017/745, certified by BSI (notified body 2797) under certificate MDR 766971.
Identifiers
| Device | Tasso+ (also covered: TassoOne Plus, Tasso Mini) |
|---|---|
| Manufacturer | Tasso, Inc., 400 2nd Ave W., Seattle, WA 98119, USA |
| Manufacturer SRN | US-MF-000017355 |
| EU authorised representative | Emergo Europe B.V., Westervoortsedijk 60, 6827 AT Arnhem, Netherlands |
| Importer named in the instructions for use | MedEnvoy Global B.V., Prinses Margrietplantsoen 33, Suite 123, 2595 AM Den Haag, Netherlands |
| Basic UDI-DI | 0850038691TassoLancetK7 |
| Classification | Class IIa, Rule 12 of Annex VIII, Regulation (EU) 2017/745 |
| Conformity assessment | Annex IX, Chapters I and III |
| Notified body | BSI Group The Netherlands B.V., number 2797 |
| Certificate | MDR 766971, valid until 24 May 2028 |
| Intended purpose | Allows self-collection of a capillary blood sample in conjunction with a compatible sample collection reservoir. |
Batch checks
Before we sell a delivery, we check CE mark, labelling, expiry date and packaging of the batch, and we record which batch went to which buyer.
Report an incident
Report serious incidents to Tasso, Inc., to Emergo Europe B.V. as EU authorised representative and to the authority of your country, in Germany the BfArM.
Please also write to orders@bloodbutton.com, so we can trace the batch and inform other buyers.