Identity
- Trade Name
- TULSA-PRO EUDAMEDFDA UDI
- Generic Name
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
- Device Name
- TULSA-PRO System EUDAMEDFDA UDI
- Model / Reference
- PAD-105 EUDAMEDFDA UDITULSA-PRO EUDAMED
- Description
- TULSA-PRO System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540281000014 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07540281000014 EUDAMED
- 510(k) Number
- K191200 FDA UDI
- FDA Product Code
- PLP FDA UDI
- EMDN Code
- Z12160303 EQUIPMENT FOR ULTRASONIC ONCOLOGY THERAPY EUDAMED
- GMDN Term
- Therapeutic oncological/gynaecological ultrasound system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4340 FDA UDI
- 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
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
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
No
FDA UDI
Tulsa-Pro by Profound Medical Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07540281000014 | 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 (2)
- EUDAMED 7158c25c-8dea-4f4d-934e-f12f00660e3c 61 fields · synced Jul 19, 2026
- FDA UDI a0d59d88-7c73-4ece-a68b-cbfc6a742e34 34 fields · synced May 30, 2026