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EUDAMED last updated this device on May 6, 2026
622554IRELIEF7HI-RELIEF is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by I-MED PHARMA Inc.. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00622554008907890(01)00622554008907
European Medical Device Nomenclature — the EU product classification assigned to this device.
M040399OPHTHALMIC DRESSINGS - OTHER1 warning recorded — scroll inside the panel to see all entries.
For external use only. Keep out of reach of children. Do not apply for more than 20 minutes at a time. Dispose of I-RELIEF mask if punctured or broken. Always test I-RELIEF mask temperature with fingers prior to use on eyes. Overheating or prolonged application may cause injury. Do not use on infants. Do not apply to sensitive skin, skin with no sensation, or open wounds. Do not boil. Overheating in a microwave may damage I-RELIEF mask. Do not ingest contents. Warm according to instructions. Do not apply if too hot. Do not fall asleep using I-RELIEF mask. People with diabetes, circulation disorders, skin infections, etc. should consult their doctor before use. Consult your doctor if your condition worsens or irritation develops. Serious incidents should be reported to the manufacturer and local competent authority.
Primary placement in Finland; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | Feb 1, 2020 | May 7, 2026 |
| EL | Nov 1, 2024 | May 7, 2026 |
| Poland | Jun 1, 2020 | May 7, 2026 |
CA-MF-000016601The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →This device is not currently linked to any other device.
No certificate specifically references this device's Basic UDI-DI.
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.