Manufacturer
Biosensors
SingaporeLegal entities : Biosensors Interventional Technologies Pte Ltd
Markets : France · Germany · Italy · Netherlands · Portugal · Spain · United States
Approvals : EU – class I, IIb · United States (FDA) – 510(k) : 5 · PMA : 1 · class II, III · latest in 2022 · see on the FDA website
Public contracts won : Spain 32 · France 29 · Italy 6 · Portugal 5 · Germany 2
EU representative : NVT GmbH (Germany)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Various instruments for cardiology and cardiac surgery - hardware accessories | Z12059080 |
|
I MDR | EUDAMED record Report an error |
| Various instruments for cardiology and cardiac surgery -other | Z12059099 | IIb MDR | EUDAMED record Report an error |
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