Manufacturer
AbbVie
United StatesLegal entities : AbbVie Inc.
Markets : Austria · Czechia · France · Germany · Ireland · Italy · Poland · Spain · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 7 · class I, II, III · latest in 2026 · see on the FDA website
Public contracts won : France 7 · Czechia 6 · Italy 6 · Spain 5 · Poland 1
EU representative : AbbVie Deutschland GmbH & Co. KG (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 |
|---|---|---|---|---|
| General medicine therapeutic treatment instruments - medical device software | Z12040292 | I, IIa MDR | EUDAMED record Report an error | |
| General medicine diagnosis and monitoring instruments - medical device software | Z12040192 | I MDR, 93/42 | EUDAMED record Report an error |
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