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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

Sunrise sensor — Class I MDR by Sunrise SA

MD Atlas
Sunrise SA

EUDAMED last updated this device on May 1, 2023

Sunrise sensor

5430001896SunriseDxSenQU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sunrise SA
UDI-DI code: 05430001896008
Reference / catalog number: A200

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Manufacturer information

Organization name: Sunrise SA
SRN: BE-MF-000000105
Manufacturer status: Active

Related devices

Sunrise sensor5430001896SunriseDxSenQUOn the market Sunrise Sleep Disorder Diagnostic Aid5430001896SUN1XX5MOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Belgium; available across 2 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
France		Still on market

Device identification

Trade name: Sunrise sensor
UDI-DI code: 05430001896008
Basic UDI-DI: 5430001896SunriseDxSenQU
Reference / catalog number: A200
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1399NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER

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