Identity
- Trade Name
- CUTIS EUDAMED
- Device Name
- CUTIS EUDAMED
- Model / Reference
- 700245 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391534610014 EUDAMED
- Basic UDI-DI
- B-05391534610014 EUDAMED
- EMDN Code
- Z12040285 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Cutis by Mirai Medical Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-05391534610014 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mirai Medical Limited
- EUDAMED SRN
- IE-MF-000002374
Sources (1)
- EUDAMED d7b456ba-7106-4a59-925d-6f2d079d7ef4 61 fields · synced Oct 6, 2026