Identity
- Trade Name
- Peloris# Dual Retort Tissue Processor EUDAMED
- Device Name
- HistoCore PELORIS EUDAMED
- Model / Reference
- 26.0005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09349458005603 EUDAMED
- Basic UDI-DI
- 9349458002DB EUDAMED
- EMDN Code
- W0202059010 TISSUE PROCESSORS EUDAMED
Classification
- Device Class
- Class A 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
Peloris# Dual Retort Tissue Processor by Leica Biosystems Melbourne Pty Ltd — 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 | 9349458002DB | Class A | Active |
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Manufacturer
- Manufacturer
- Leica Biosystems Melbourne Pty Ltd
- EUDAMED SRN
- AU-MF-000016740
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 3ccf26fb-b60b-4cac-afbc-28cbfacec518 61 fields · synced Jul 8, 2026