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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 Safesheet — Class I MDR by CMC HYGEA LTD

MD Atlas
CMC HYGEA LTD

EUDAMED last updated this device on Jul 4, 2022

PathAguard Safesheet

539152805013CK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CMC HYGEA LTD
UDI-DI code: 05391528050147
Reference / catalog number: CMCSS10001A

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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
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: PathAguard Safesheet
UDI-DI code: 05391528050147
Basic UDI-DI: 539152805013CK
Reference / catalog number: CMCSS10001A
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: The PathAguard Safesheet is a unique Medical Device designed to protect equipment during storage and provide a clean ad hygenic surface cover in clinical and community settings.
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.