Identity
- Device Name
- Aperio GT 450 SAM DX Software EUDAMED
- Model / Reference
- 23SAMSWDXIVD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815477020389 EUDAMED
- Basic UDI-DI
- 0815477020389WY EUDAMED
- EMDN Code
- W0202050304 DIGITAL LABORATORY MICROSCOPES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
New Device
No
EUDAMED
Aperio GT 450 SAM DX Software by Leica Biosystems Imaging, Inc. — 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 | 0815477020389WY | Class A | Active |
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Manufacturer
- Manufacturer
- Leica Biosystems Imaging, Inc.
- EUDAMED SRN
- US-MF-000020547
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 58752392-e0a5-4888-be9d-7ab44c0726a1 61 fields · synced Jul 12, 2026