Identity
- Trade Name
- 3 Treatment Water Kit EUDAMED
- Device Name
- 3 Treatment Water Kit EUDAMED
- Model / Reference
- SET000841-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290015461818 EUDAMED
- Basic UDI-DI
- 7290015461WatrKitSET841KK EUDAMED
- EMDN Code
- Z120610 ULTRASOUND THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
3 Treatment Water Kit 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 | 7290015461WatrKitSET841KK | 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 16c8d566-2f9e-4bf8-bdf7-012b10ac473a 61 fields · synced Jun 11, 2026