Identity
- Trade Name
- BOND-PRIME Processing Module EUDAMEDBOND-PRIME automated stainer FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- BOND Processing Module EUDAMEDThe BOND system is designed for immunostaining histological specimens mounted on microscope slides. FDA UDI
- Model / Reference
- 91.0021 EUDAMEDBOND-PRIME FDA UDI
- Description
- The BOND system is designed for immunostaining histological specimens mounted on microscope slides. FDA UDI
Identifiers
- Catalog Number
- 91.0021 FDA UDI
- Primary DI / UDI-DI
- 09349458004828 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
Category: Microscope slide stainer IVD
BOND-PRIME Processing Module by Leica Biosystems Melbourne Pty Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 6503da5d-bc3c-4cf7-b764-7cbd3e88455d 61 fields · synced Jun 17, 2026
- FDA UDI f2adc7e5-e4b2-4eaa-bf61-9bc0c1d82585 34 fields · synced May 25, 2026