Identity
- Trade Name
- BOND Controller (6.0/W10 loT) EUDAMEDBOND FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- BOND Processing Module EUDAMEDThe BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that controls the processing Module(s). FDA UDI
- Model / Reference
- S21.4621 EUDAMEDBOND Controller (6.0/W10 loT) FDA UDI
- Description
- The BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that controls the processing Module(s). FDA UDI
Identifiers
- Catalog Number
- S21.4621 FDA UDI
- Primary DI / UDI-DI
- 09349458004859 EUDAMEDFDA UDI
- Basic UDI-DI
- 9349458001D9 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202050380 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - HARDWARE ACCESSORIES 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microscope slide stainer IVD
Bond by Leica Biosystems Melbourne Pty Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Melbourne Pty Ltd
Sources (2)
- FDA UDI f0465639-2da5-4917-868a-0c1bb52fe257 34 fields · synced Jun 18, 2026
- EUDAMED 8dd19f5b-c986-41e4-ac94-edb7e101df62 61 fields · synced Jun 18, 2026