Identity
- Trade Name
- HI-REX EUDAMED
- Device Name
- High Intensity Focused Ultrasound EUDAMED
- Model / Reference
- HI-REX EUDAMEDAMI-CL-0841 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800042100223 EUDAMED
- Basic UDI-DI
- B-08800042100223 EUDAMED
- EMDN Code
- Z120610 ULTRASOUND THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
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
Hi-Rex by Ami Inc. — Class IIa — 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-08800042100223 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ami Inc.
- EUDAMED SRN
- KR-MF-000017522
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 5cf5f11b-fd2e-48fa-a69a-3b3c3202cf1c 61 fields · synced Sep 17, 2026