Identity
- Device Name
- Optase Heat Mask Pro EUDAMED
- Model / Reference
- FROPTASE-HMPro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391531761788 EUDAMED
- Basic UDI-DI
- 5391531optaseMHM02JN EUDAMED
- Direct Marketing DI
- 05391531761788 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Optase Heat Mask Pro by Scope Ophthalmics Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5391531optaseMHM02JN | Class I | Active |
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Manufacturer
- Manufacturer
- Scope Ophthalmics Limited
- EUDAMED SRN
- IE-MF-000037510
Sources (1)
- EUDAMED 00b5d784-82b1-4237-80a9-42899e81c79d 61 fields · synced Jul 23, 2026