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Donatello Series
EUDAMEDClass A (EU MDR)
Ref SDSDT9000Model AUTOMATIC TISSUE PROCESSOR
Identity
- Trade Name
- DONATELLO SERIES EUDAMED
- Device Name
- DONATELLO EUDAMED
- Model / Reference
- AUTOMATIC TISSUE PROCESSOR EUDAMEDSDSDT9000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033895011501 EUDAMED
- Basic UDI-DI
- 8033895W0202059010E7 EUDAMED
- Direct Marketing DI
- 08033895011501 EUDAMED
- EMDN Code
- W0202059010 TISSUE PROCESSORS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Donatello Series by Diapath S.p.A. società a socio unico — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8033895W0202059010E7 | Class A | Active |
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Manufacturer
- Manufacturer
- Diapath S.p.A. società a socio unico
- EUDAMED SRN
- IT-MF-000027016
Sources (1)
- EUDAMED f2aa0a7a-4dc5-4b7a-8f4e-51411cea5dd0 61 fields · synced Oct 6, 2026