Identity
- Trade Name
- EPORE Generator EUDAMED
- Device Name
- ePORE Generator EUDAMED
- Model / Reference
- MMHT1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391534610090 EUDAMED05391534610083 EUDAMED
- Basic UDI-DI
- B-05391534610090 EUDAMEDB-05391534610083 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
Similar devices
Also classified as Dermatological laser beam guiding handpiece.
- GentleYAG 1.5/3MM Delivery System W/DCD — Candela Corporation · Class II
- Clear & Brilliant — Solta Medical, Inc. · Class II
- hydrosun 750 — Hydrosun Medizintechnik GmbH · Class IIa
- GentleYAG 3MM Delivery System W/O DCD — Candela Corporation · Class II
- External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima — Candela Corporation · Class II
- TL 30 — Globalcare Medical Technology Co., Ltd. · Class IIa
- Open — Candela Corporation · Class II
- HydraFacial — Hydrafacial LLC · Class I
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-05391534610090 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mirai Medical Limited
- EUDAMED SRN
- IE-MF-000002374
Sources (2)
- EUDAMED 37b841fb-622c-4252-975a-21db90ff8b52 61 fields · synced Jul 11, 2026
- EUDAMED 387c1c64-aa1c-430a-9d38-08158c87777f 61 fields · synced May 17, 2026