Identity
- Trade Name
- Vaginal Pressure Probe EUDAMEDFDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Device Name
- Vaginal Pressure Probe EUDAMED
- Model / Reference
- SA9005 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540191000616 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540191000619B EUDAMED
- 510(k) Number
- K201014 FDA UDI
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
- GMDN Term
- Psychophysiological biofeedback system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vaginal Pressure Probe by Thought Technology Ltd. — 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 | 7540191000619B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thought Technology, Ltd.
- EUDAMED SRN
- CA-MF-000024010
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d6476c4e-10e2-461c-ac8e-bfa1d2314880 61 fields · synced Jul 13, 2026
- FDA UDI 1e25a3a4-8550-42f6-8d25-aa335b27ddad 33 fields · synced May 30, 2026