Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

PathAguard LUCA Dispenser — Class I MDR by CMC HYGEA LTD

MD Atlas
CMC HYGEA LTD

EUDAMED last updated this device on Feb 10, 2022

PathAguard LUCA Dispenser

539152805004CJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CMC HYGEA LTD
UDI-DI code: 05391528050048
Reference / catalog number: CMCD10002A

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

CMC HYGEA LTD539152805021CJOn the market PathAguard ABLiS Basin539152805000CAOn the market PathAguard ABLiS Basin Carrier539152805006CNOn the market PathAguard ABLiS Basin Liner539152805001CCOn the market PathAguard Liner Dispenser539152805002CEOn 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.

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 Dispenser
UDI-DI code: 05391528050048
Basic UDI-DI: 539152805004CJ
Reference / catalog number: CMCD10002A
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