Identity
- Trade Name
- Duodopa SC Dose Calculator EUDAMED
- Device Name
- PRODUODOPA/DUODOPA/DUODOPA SC/VYALEV/SCYOVA (foslevodopa/foscarbidopa) Dose Calculator EUDAMED
- Model / Reference
- 0AV945 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054083025391 EUDAMED
- Basic UDI-DI
- 8054083000V0AV945YE EUDAMED
- EMDN Code
- Z12040292 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Duodopa SC Dose Calculator by Abbvie Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8054083000V0AV945YE | Class IIa | Active |
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Manufacturer
- Manufacturer
- AbbVie Inc.
- EUDAMED SRN
- US-MF-000014055
- Authorised Representative
- Allergan Pharmaceuticals International Limited IE-AR-000000650
Sources (1)
- EUDAMED fbf4c8f4-e077-4276-a9b6-520253e7f709 61 fields · synced Aug 1, 2026