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Barco
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref K9301100A2XModel Pathology Display
by Barco NV
Identity
- Trade Name
- Barco EUDAMEDFDA UDI
- Generic Name
- Digital pathology image display unit IVD FDA UDI
- Device Name
- MDPC-8127 EUDAMEDFDA UDI
- Model / Reference
- Pathology Display EUDAMEDK9301100A2X EUDAMEDMDPC-8127 FDA UDI
- Description
- MDPC-8127 FDA UDI
Identifiers
- Catalog Number
- K9301100A2X FDA UDI
- Primary DI / UDI-DI
- 05415334044289 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_Pathology_X4 EUDAMED
- FDA Product Code
- PSY FDA UDI
- EMDN Code
- Z11069082 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Digital pathology image display unit IVD FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.3700 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
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
Yes
FDA UDI
Barco by Barco NV — Class IIa — MDR, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5415334_Pathology_X4 | Class IIa | Active |
| EUDAMED | European Union | CE/IVDR | 5415334_Pathology_X4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Barco NV
- EUDAMED SRN
- BE-MF-000000690
Sources (2)
- EUDAMED 511b7846-4d90-42ef-b095-5b23d30d889b 61 fields · synced May 29, 2026
- FDA UDI 4c8958b6-3fbe-4107-a1cd-7faffe0fa465 35 fields · synced May 29, 2026