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Organization name
UDI-DI code
Reference / catalog number

SSL_KEWS_002 — Class IIb MDD by Syncrophi Systems Ltd

MD Atlas
Syncrophi Systems Ltd

EUDAMED last updated this device on Mar 11, 2025

SSL_KEWS_002

B-53915461200062

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Syncrophi Systems Ltd
UDI-DI code: 53915461200062
Reference / catalog number: SSL_KEWS_002

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Manufacturer information

Organization name: Syncrophi Systems Ltd
SRN: IE-MF-000038815
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW999
WARNING It is possible for KEWS300 data to go unnoticed if interruptions occur in power or system operations. To help reduce this possible occurrence, it is strongly recommended that KEWS300 system be installed with redundant power supplies and redundant means of operator surveillance such as secondary Central Station KEWS300 Client and a standby KEWS300 Server.
CW999
WARNING Do not modify any aspect of KEWS300 without authorisation from SyncroPhi Systems.
CW011
PRECAUTION KEWS300 does not perform a diagnostic function as the data it collects simply presents the recorded data and corresponding early warning score and escalation protocol, if applicable. The clinician is responsible for determining the significance of the patient data.
CW999
WARNING KEWS300 should not be used in a care environment where the momentary loss of connection is unacceptable.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 53915461200062
Basic UDI-DI: B-53915461200062
Reference / catalog number: SSL_KEWS_002
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: KEWS300 system
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030201CENTRAL INFORMATION COMPUTING SYSTEMS

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

Related devices

This device is not currently linked to any other device.

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.