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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Barco — Class I MDR by Barco NV

MD Atlas
Barco NV

EUDAMED last updated this device on Oct 31, 2024

Barco

5415334_Surgical-BE_9B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Barco NV
UDI-DI code: 05415334048553
Reference / catalog number: K9352800

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Manufacturer information

Organization name: Barco NV
SRN: BE-MF-000000690
Manufacturer status: Active

Related devices

Barco5415334_Surgical-BE_9BOn the market Barco5415334_Surgical-BE_9BOn the market Barco5415334_Surgical-BE_9BOn the market Barco5415334_Surgical-BE_9BOn the market Barco5415334_Surgical-BE_9BOn the market

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: Barco
UDI-DI code: 05415334048553
Basic UDI-DI: 5415334_Surgical-BE_9B
Reference / catalog number: K9352800
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: MDEC-2523
Additional information URL: https://www.barco.com/en/healthcare
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11900802BIOIMAGING VIEWING MONITORS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

G10 082788 0022Issued
Quality management systemNotified body: 0123Expiry: Jan 26, 2028