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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

Medicare Eye Patch — Class I MDR by Fleming Medical

MD Atlas
Fleming Medical

EUDAMED last updated this device on Apr 16, 2026

Medicare Eye Patch

5099390EyePaFV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fleming Medical
UDI-DI code: 05099390412758
Reference / catalog number: MD400013

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Manufacturer information

Organization name: Fleming Medical
SRN: IE-MF-000044303
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Due to individual differences in physical constitution, if you experience allergies or discomfort during use, please stop using it immediately.  This product is intended for prevention and improvement, and does not have medical treatment effects. It is recommended to wash gently by hand. The eye mask contains fillers, so do not rub it vigorously, as this will affect its appearance and service life.

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: Medicare Eye Patch
UDI-DI code: 05099390412758
Basic UDI-DI: 5099390EyePaFV
Reference / catalog number: MD400013
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: It is shaped for comfort and protection for eyes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0299OPHTHALMIC 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

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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.