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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 ABLiS Basin Liner — Class I MDR by CMC HYGEA LTD

MD Atlas
CMC HYGEA LTD

EUDAMED last updated this device on Feb 10, 2022

PathAguard ABLiS Basin Liner

539152805001CC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CMC HYGEA LTD
UDI-DI code: 05391528050017
Reference / catalog number: CMCL10001A

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Manufacturer information

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

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	Apr 1, 2020	Still on market
XI	Apr 1, 2020	Still on market

Device identification

Trade name: PathAguard ABLiS Basin Liner
UDI-DI code: 05391528050017
Basic UDI-DI: 539152805001CC
Reference / catalog number: CMCL10001A
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-ablis-patient-bathing-system/
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

Related devices

CMC HYGEA LTD539152805021CJOn the market PathAguard ABLiS Basin539152805000CAOn the market PathAguard ABLiS Basin Carrier539152805006CNOn the market PathAguard Liner Dispenser539152805002CEOn the market PathAguard LUCA539152805009CUOn 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.