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Barco
EUDAMEDFDA UDIClass I (EU MDR)
Ref 215EFOEUModel surgical monitor
by Barco, Inc.
Identity
- Trade Name
- Barco EUDAMEDFDA UDI
- Generic Name
- Image display unit, colour FDA UDI
- Device Name
- AMM215WTTP, AMM215WTD, AMM240ED EUDAMEDLCD Color Display FDA UDI
- Model / Reference
- surgical monitor EUDAMED215EFOEU EUDAMEDAMM215WTD FDA UDI
- Description
- LCD Color Display FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00700621719298 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415334_Surgical-US_DL 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, Inc. — 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-US_DL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Barco, Inc.
- EUDAMED SRN
- US-MF-000018743
- Authorised Representative
- Barco NV BE-AR-000003385
Sources (2)
- EUDAMED 292443b2-d4c3-4971-87e2-cbc363af01ac 61 fields · synced Jun 8, 2026
- FDA UDI c1543636-1c3f-48bd-a274-0948672aea66 34 fields · synced May 30, 2026