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Sonalleve
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 451000080776Model SONALLEVE MR-HIFU V2 ACHIEVA 3TModel SONALLEVE MR-HIFU
Identity
- Trade Name
- Sonalleve EUDAMEDFDA UDISONALLEVE MR-HIFU V2 ACHIEVA 3T EUDAMED
- Generic Name
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
- Device Name
- Sonalleve MR-HIFU EUDAMEDSONALLEVE MR-HIFU V2 ACHIEVA 3T FDA UDI
- Model / Reference
- SONALLEVE MR-HIFU V2 ACHIEVA 3T EUDAMED451000080776 EUDAMEDFDA UDISONALLEVE MR-HIFU EUDAMED
- Description
- SONALLEVE MR-HIFU V2 ACHIEVA 3T FDA UDI
Identifiers
- Catalog Number
- 451000080776 FDA UDI
- Primary DI / UDI-DI
- 07540281000243 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07540281000243 EUDAMED75402810200097 EUDAMED
- Direct Marketing DI
- 07540281000243 EUDAMED
- PMA Number
- H190003 FDA UDI
- FDA Product Code
- QND FDA UDI
- EMDN Code
- Z1204021501 MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT EUDAMED
- GMDN Term
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Sonalleve by Profound Medical Inc. — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07540281000243 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-07540281000243 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Profound Medical Inc.
- EUDAMED SRN
- CA-MF-000028761
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 1ff0f539-56d9-4d3a-b673-5797fed46930 61 fields · synced Jul 15, 2026
- EUDAMED 887a8eef-4ab1-465f-8f36-f7fa3bca75bc 61 fields · synced May 17, 2026
- FDA UDI ba08b895-14a6-4779-8e8a-299a36fbd2a2 35 fields · synced May 30, 2026