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Eonis
EUDAMEDFDA UDIClass I (EU MDR)
Ref K9307945BModel Clinical Review Display
by Barco NV
Identity
- Trade Name
- Eonis EUDAMEDBarco FDA UDI
- Generic Name
- Image display unit, colour FDA UDI
- Device Name
- MDRC-1219, MDRC-2222, MDRC-1219 HB, MDRC-1219 HB TS, MDRC-1419, MDRC-2422, MDRC-2424, MDRC-8132, MDRC-2421, MDRC-8127 EUDAMEDMDRC-2222 WP MK2 FDA UDI
- Model / Reference
- Clinical Review Display EUDAMEDK9307945B EUDAMEDMDRC-2222 FDA UDI
- Description
- MDRC-2222 WP MK2 FDA UDI
Identifiers
- Catalog Number
- K9307945B FDA UDI
- Primary DI / UDI-DI
- 05415334039742 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_Clinical-BE_AV EUDAMED
- FDA Product Code
- LMD 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
- 892.2020 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
Eonis 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_Clinical-BE_AV | 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 fccb1894-99ed-43a9-b656-93dcbdc8905c 61 fields · synced Jun 18, 2026
- FDA UDI f792070f-0c71-498d-a1f9-c59464c4a6b9 35 fields · synced May 30, 2026