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Barco
EUDAMEDFDA UDIClass A (EU MDR)
Ref K9301101AModel 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 EUDAMEDMDPC-8127 HOL FDA UDI
- Model / Reference
- Pathology Display EUDAMEDK9301101A EUDAMEDMDPC-8127 FDA UDI
- Description
- MDPC-8127 HOL FDA UDI
Identifiers
- Catalog Number
- K9301101A FDA UDI
- Primary DI / UDI-DI
- 05415334056251 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_Patho-IVD_VT EUDAMED
- FDA Product Code
- PSY FDA UDI
- EMDN Code
- W0202050380 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Digital pathology image display unit IVD FDA UDI
Classification
- Device Class
- Class A 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
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
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
Yes
FDA UDI
Barco by Barco NV — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 5415334_Patho-IVD_VT | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Barco NV
- EUDAMED SRN
- BE-MF-000000690
Sources (2)
- EUDAMED 862f78fa-e21a-4a85-b311-501237650b2e 61 fields · synced May 30, 2026
- FDA UDI dc90e87a-216e-4d0c-b4e6-59205645e917 35 fields · synced May 30, 2026