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Barco
EUDAMEDFDA UDIClass I (EU MDR)
Ref 991932391001Model Surgical Display
by Barco NV
Identity
- Trade Name
- Barco EUDAMEDFDA UDI
- Generic Name
- Image display unit, colour FDA UDI
- Device Name
- MDSC-8255, MDSC-8232, MDSC-8232 M3D, MDSC-8358, MDSC-8331, AR 3250-3209, JMFS314KB, MDSC-8527, AR-3250-2701, MDSC-8532, AR-3250-3211, MDEC-2523, VividImage 32 4K EUDAMEDMDSC-8331 LED FDA UDI
- Model / Reference
- Surgical Display EUDAMED991932391001 EUDAMEDMDSC-8331 FDA UDI
- Description
- MDSC-8331 LED FDA UDI
Identifiers
- Catalog Number
- 991932391001 FDA UDI
- Primary DI / UDI-DI
- 05415334001954 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_Surgical-BE_9B EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Z11900802 BIOIMAGING VIEWING MONITORS EUDAMED
- GMDN Term
- Image display unit, colour FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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
Yes
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 I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5415334_Surgical-BE_9B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Barco NV
- EUDAMED SRN
- BE-MF-000000690
Sources (2)
- EUDAMED d04bd3c9-60ca-47a7-aa7f-b213d3e48327 61 fields · synced Jul 17, 2026
- FDA UDI 0941ba10-81f8-4195-a37b-7672ccab9019 35 fields · synced May 30, 2026