BOND-III Processing Module Laboratory - Automated Slide Stainer
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- BOND-III Processing Module Laboratory - Automated Slide Stainer EUDAMEDBOND-III processing module FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- BOND Processing Module EUDAMEDThe BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis. FDA UDI
- Model / Reference
- 21.2201 EUDAMEDBOND-III FDA UDI
- Description
- The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis. FDA UDI
Identifiers
- Catalog Number
- 21.2201 FDA UDI
- Primary DI / UDI-DI
- 09349458000004 EUDAMEDFDA UDI
- Basic UDI-DI
- 9349458001D9 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Microscope slide stainer IVD
BOND-III Processing Module Laboratory - Automated Slide Stainer by Leica Biosystems Melbourne Pty Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 9349458001D9 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Melbourne Pty Ltd
- EUDAMED SRN
- AU-MF-000016740
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 0060c26c-9c89-40e9-9157-5577080dfeb9 61 fields · synced Jul 27, 2026
- FDA UDI be3fef92-fa96-4c83-9610-e0fae9563e58 34 fields · synced May 29, 2026