Identity
- Trade Name
- AUS2 EUDAMED
- Device Name
- Automatic slide stainer EUDAMED
- Model / Reference
- AUS2 EUDAMEDhttps://www.intelsint.com/aus2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034003040055 EUDAMED
- Basic UDI-DI
- 8034003040055-W2059002LA EUDAMED
- Direct Marketing DI
- 08034003040055 EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS 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
Category: Microscope slide stainer IVD
Aus2 by Intelsint S.r.l. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8034003040055-W2059002LA | Class A | Active |
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Manufacturer
- Manufacturer
- Intelsint S.r.l.
- EUDAMED SRN
- IT-MF-000030618
Sources (1)
- EUDAMED 6535bd5c-9227-4dca-ad60-5fad7e872492 61 fields · synced Jul 10, 2026