Identity
- Trade Name
- Water Path Kit EUDAMEDFDA UDI
- Generic Name
- Invasive ultrasound transducer cooling/coupling support kit FDA UDI
- Device Name
- Sonablate HIFU consumables EUDAMED
- Model / Reference
- 411-12017-0001 EUDAMED403-02200-0020-I FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850071153088 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850071153HIFUkitsX2 EUDAMED
- EMDN Code
- Z12160385 PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Invasive ultrasound transducer cooling/coupling support kit FDA UDI
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Water Path Kit by Focus Surgery, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00850071153HIFUkitsX2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Focus Surgery, Inc.
- EUDAMED SRN
- US-MF-000012164
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 9d3f0c61-fd65-464e-bafd-720c98270487 61 fields · synced Jul 17, 2026
- FDA UDI 222fc0bc-911d-4a66-a0db-a77bce74828b 32 fields · synced May 30, 2026