Identity
- Trade Name
- Aperio HALO AP EUDAMED
- Device Name
- Aperio HALO AP EUDAMED
- Model / Reference
- 23HALOAP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815477020785 EUDAMED
- Basic UDI-DI
- 0815477020785XC EUDAMED
- Direct Marketing DI
- 00815477020785 EUDAMED
- EMDN Code
- W0202050382 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Aperio HALO AP 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 | 0815477020785XC | 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 5b8c1717-7a01-4837-b12a-5cfa5f854f6b 61 fields · synced Jul 8, 2026