Identity
- Trade Name
- EPORE Generator EUDAMED
- Device Name
- EPORE Generator EUDAMED
- Model / Reference
- MMHT1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391534610021 EUDAMED
- Basic UDI-DI
- B-05391534610021 EUDAMED
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dermatological laser beam guiding handpiece
EPORE Generator by Mirai Medical Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391534610021 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mirai Medical Limited
- EUDAMED SRN
- IE-MF-000002374
Sources (1)
- EUDAMED c6e3d830-db90-404c-a84c-f5e7fa461020 61 fields · synced Jun 19, 2026