← Back to catalogue
Barco
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref K9353013Model Surgical Display
by Barco, Inc.
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-8532 SSTF M2 FDA UDI
- Model / Reference
- Surgical Display EUDAMEDK9353013 EUDAMEDMDSC-8532 FDA UDI
- Description
- MDSC-8532 SSTF M2 FDA UDI
Identifiers
- Catalog Number
- K9353013 FDA UDI
- Primary DI / UDI-DI
- 05415334050082 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_Surgical-BE_9B EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER 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
Yes
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
Category: Image display unit, colour
Barco by Barco, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Image display unit, colour.
- LG — Lg Electronics · Class I
- Radiance — NDS SURGICAL IMAGING, LLC. · Class I
- LG — Lg Electronics · Class II
- RadiForce® — EIZO CORPORATION · Class I
- EndoVue — NDS SURGICAL IMAGING, LLC. · Class I
- RadiForce® — EIZO CORPORATION · Class I
- Radiance — NDS SURGICAL IMAGING, LLC. · Class I
- RadiForce® — EIZO CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Barco, Inc.
Sources (2)
- FDA UDI 213ee598-c6a9-4fc1-bbd4-73c9b2df9d54 35 fields · synced Jul 10, 2026
- EUDAMED 5a5f31f7-f225-440f-bbc8-8c592b181502 61 fields · synced Jun 18, 2026