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Upgrade to Philips IntelliSite Pathology Solution 5.x - IVDR
EUDAMEDFDA UDIClass A (EU MDR)
Ref 760045
Identity
- Trade Name
- Upgrade to Philips IntelliSite Pathology Solution 5.x - IVDR EUDAMEDPhilips IntelliSite Pathology Solution FDA UDI
- Generic Name
- Microscope slide digital imaging scanner IVD FDA UDI
- Device Name
- Philips IntelliSite Pathology Solution EUDAMEDWhole Slide Imaging System. The device is an automated digital slide creation, viewing and management system. FDA UDI
- Model / Reference
- 760045 EUDAMED5.1 upgrade FDA UDI
- Description
- Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system. FDA UDI
Identifiers
- Catalog Number
- 760045 FDA UDI
- Primary DI / UDI-DI
- 00884838121270 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM847TU EUDAMED
- FDA Product Code
- PSY FDA UDI
- EMDN Code
- W0202050304 DIGITAL LABORATORY MICROSCOPES EUDAMED
- GMDN Term
- Microscope slide digital imaging scanner IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.3700 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Upgrade to Philips IntelliSite Pathology Solution 5.x - IVDR by Philips Medical Systems Nederland B.V. — 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 | 0884838BM847TU | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED c6bb6ac8-8128-4ef4-a943-191f066b4661 61 fields · synced Oct 6, 2026
- FDA UDI 1064f2af-d14c-44d4-b7c5-d3c7923328ad 35 fields · synced May 30, 2026