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I-RELIEF Hot and Cold Therapy Eye Mask
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 890
Identity
- Trade Name
- I-RELIEF EUDAMEDI-RELIEF Hot and Cold Therapy Eye Mask FDA UDI
- Generic Name
- Eye heat therapy pack, reusable FDA UDI
- Device Name
- I-RELIEF Hot and Cold Therapy Eye Mask EUDAMEDHot & Cold Therapy Eye Mask with ThermaBeadsTM for the relief of symptoms associated with Blepharitis, Dry Eye Disease, Meibomian Gland Disease (MGD), Styes and Chalazia as well as headaches, sinus pressure, tension, swelling and puffiness. FDA UDI
- Model / Reference
- 890 EUDAMED0890 FDA UDI
- Description
- Hot & Cold Therapy Eye Mask with ThermaBeadsTM for the relief of symptoms associated with Blepharitis, Dry Eye Disease, Meibomian Gland Disease (MGD), Styes and Chalazia as well as headaches, sinus pressure, tension, swelling and puffiness. FDA UDI
Identifiers
- Catalog Number
- 0890 FDA UDI
- Primary DI / UDI-DI
- 00622554008907 EUDAMEDFDA UDI
- Basic UDI-DI
- 622554IRELIEF7H EUDAMED
- FDA Product Code
- IME FDA UDI
- EMDN Code
- M040399 OPHTHALMIC DRESSINGS - OTHER EUDAMED
- GMDN Term
- Eye heat therapy pack, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5700 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Eye heat therapy pack, reusable
I-RELIEF Hot and Cold Therapy Eye Mask by I-Med Pharma Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- I-Med Pharma Inc
Sources (2)
- FDA UDI d5aca48e-2e10-4d29-b9f6-25f093c551e4 35 fields · synced Jul 14, 2026
- EUDAMED 55751421-d26a-4581-8fb5-986ebd079a7f 61 fields · synced Jul 14, 2026