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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

FROPTASE-HMPro — Class I MDR by Scope Ophthalmics Limited

MD Atlas
Scope Ophthalmics Limited

EUDAMED last updated this device on May 1, 2026

FROPTASE-HMPro

5391531optaseMHM02JN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Scope Ophthalmics Limited
UDI-DI code: 05391531761788
Reference / catalog number: FROPTASE-HMPro

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Manufacturer information

Organization name: Scope Ophthalmics Limited
SRN: IE-MF-000037510
Manufacturer status: Active

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW999
Do not use on broken, damaged, infected or inflamed periocular skin.
CW999
Do not exceed the heating times stated in the Instructions for Use. Absolute maximum heating time is 30 seconds. Wattage-dependent recommended times: up to 800W, do not exceed 25 seconds; 900W and above, do not exceed 15 seconds. Always check the temperature on the wrist before applying to closed eyelids.
CW999
Use with caution if you have poor circulation or reduced sensation, including due to diabetes. Do not use on individuals unable to communicate discomfort without continuous adult supervision.
CW999
Do not use while sleeping. Adult supervision is required at all times when the device is used on or by children.
CW999
Do not leave the device unattended while heating in the microwave. Wait 30 minutes before reheating.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement	Aug 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05391531761788
Basic UDI-DI: 5391531optaseMHM02JN
Reference / catalog number: FROPTASE-HMPro
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: 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.