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Organization name
UDI-DI code
Reference / catalog number

CMC HYGEA LTD — Class I MDR by CMC HYGEA LTD

MD Atlas
CMC HYGEA LTD

EUDAMED last updated this device on May 8, 2024

CMC HYGEA LTD

539152805021CJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CMC HYGEA LTD
UDI-DI code: 05391528050215
Reference / catalog number: N/A

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Manufacturer information

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

Market distribution

Primary placement in Hungary; available across 1 country total.

Placed on the market in Hungary; per-country availability dates not published.

Device identification

Trade name: CMC HYGEA LTD
UDI-DI code: 05391528050215
Basic UDI-DI: 539152805021CJ
Reference / catalog number: N/A
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: Multipurpose Compostable Liner for the containment of human waste and incontinence products.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V80CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES

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

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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.