Identity
- Trade Name
- Exablate Scar Patch EUDAMED
- Device Name
- Exablate Scar Patch EUDAMED
- Model / Reference
- SET000554-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290015461801 EUDAMED
- Basic UDI-DI
- 7290015461ScrPtchSET5544A EUDAMED
- EMDN Code
- Z120610 ULTRASOUND THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Exablate Scar Patch by Insightec Ltd — 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 | 7290015461ScrPtchSET5544A | Class I | Active |
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Manufacturer
- Manufacturer
- InSightec Ltd.
- EUDAMED SRN
- IL-MF-000011795
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 1c8193c8-295f-4e59-8a65-7ed5f04e6e17 61 fields · synced Jun 19, 2026