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Sign in to claim this brandLEICA BIOSYSTEMS MELBOURNE PTY LTD
Australia·AU-MF-000016740
Last updated September 17, 2026
Information
- Country
- Australia
- Address
- 495 , Blackburn Road, Mt Waverley, Australia
- Website
- www.leicabiosystems.com/
- —
- —
- [email protected]
- Phone
- +61392117400
- PRRC Contact
- Raman Aulakh
- EUDAMED SRN
- AU-MF-000016740
- FDA FEI Number
- 3006461677
- DUNS Number
- —
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Peloris# Dual Retort Tissue Processor | 26.0005 | EUDAMED | Class A | Active |
| BOND-PRIME Processing Module | RS91.0021 | EUDAMEDFDA UDI | Class A | Active |
| BOND-III Processing Module Laboratory - Automated Slide Stainer | RS21.2201 | EUDAMEDFDA UDI | Class A | Active |
| BOND-MAX Processing Module Laboratory - Automated Slide Stainer | RS49.0051 | EUDAMEDFDA UDI | Class A | Active |
| BOND-MAX Processing Module Laboratory - Automated Slide Stainer | 49.0051 | EUDAMEDFDA UDI | Class A | Active |
| BOND-PRIME Processing Module | 91.0021 | EUDAMEDFDA UDI | Class A | Active |
| BOND-III Processing Module Laboratory - Automated Slide Stainer | 21.2201 | EUDAMEDFDA UDI | Class A | Active |
Related Companies
Authorised Representatives
- CEpartner4U NL
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 2, 2025 | Z-1683-2025 | — | open, classified | There is a leakage issue associated with the tubing in the manifold of the instrument. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Leica Biosystems Melbourne Pty Ltd US