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BOND-III Processing Module Laboratory - Automated Slide Stainer
EUDAMEDFDA UDIClass A (EU MDR)
Ref RS21.2201
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
- RS21.2201 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
- RS21.2201 FDA UDI
- Primary DI / UDI-DI
- 09349458005672 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
BOND-III Processing Module Laboratory - Automated Slide Stainer by Leica Biosystems Melbourne Pty Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
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 e5fcc2ad-2791-43be-8a20-1b60281e3c19 61 fields · synced Jun 18, 2026
- FDA UDI 4e1c652a-54d7-40a2-bc58-f6b5341131f3 34 fields · synced May 30, 2026