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Optase Cooling Mask
EUDAMEDClass I (EU MDR)
Ref FROPTASE-COOL MASKModel KK-CH-III180
Identity
- Trade Name
- Optase Cooling Mask EUDAMED
- Device Name
- Cooling Mask EUDAMED
- Model / Reference
- KK-CH-III180 EUDAMEDFROPTASE-COOL MASK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391531760644 EUDAMED
- Basic UDI-DI
- 5397252coolmaskDJ EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES 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
Yes
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
Category: Hot/cold therapy pack, reusable
Optase Cooling Mask by Scope Ophthalmics Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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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 | 5397252coolmaskDJ | Class I | Active |
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Manufacturer
- Manufacturer
- Scope Ophthalmics Limited
- EUDAMED SRN
- IE-MF-000037510
Sources (1)
- EUDAMED 6ac4e54f-06b4-412a-a0d2-143477ca1d7c 61 fields · synced Jul 11, 2026