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Aperio GT 450 DX
EUDAMEDFDA 510(k)Class A (EU MDR)
Ref 23GT450DXIVDModel Aperio GT 450 DX
Identity
- Device Name
- Aperio GT 450 DX EUDAMED
- Model / Reference
- Aperio GT 450 DX EUDAMED23GT450DXIVD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815477020297 EUDAMED
- Basic UDI-DI
- 0815477020297WS EUDAMED
- Direct Marketing DI
- 00815477020297 EUDAMED
- EMDN Code
- W0202050304 DIGITAL LABORATORY MICROSCOPES EUDAMED
Classification
- Device Class
- Class A 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
Yes
EUDAMED
New Device
No
EUDAMED
Aperio GT 450 DX by Leica Biosystems Imaging, Inc. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232202 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 0815477020297WS | 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 (2)
- EUDAMED 90849fb6-34db-4699-af1f-4682aeaa1031 61 fields · synced Jul 21, 2026
- FDA 510(k) K232202 1 fields · synced May 18, 2026