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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

PathAguard LUCA Large — Class I MDR by CMC HYGEA LTD

MD Atlas
CMC HYGEA LTD

EUDAMED last updated this device on Feb 10, 2022

PathAguard LUCA Large

539152805008CS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CMC HYGEA LTD
UDI-DI code: 05391528050086
Reference / catalog number: CMCU10002A

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Manufacturer information

Organization name: CMC HYGEA LTD
SRN: IE-MF-000005163
Manufacturer status: Active

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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.

CW010
Internationally recognized symbol for instructions for use

Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement	May 1, 2020	Still on market
XI	May 1, 2020	Still on market

Device identification

Trade name: PathAguard LUCA Large
UDI-DI code: 05391528050086
Basic UDI-DI: 539152805008CS
Reference / catalog number: CMCU10002A
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: https://cmchygea.com/pathaguard-luca-ulcer-care-wound-management/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y093399WASHING, BATHING AND SHOWERING DEVICES - 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