Identity
- Trade Name
- FemiScan FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by using EMG-signals. FDA UDI
- Model / Reference
- HTCS-2 FDA UDI
- Description
- FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by using EMG-signals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430035220014 FDA UDI
- 510(k) Number
- K993411 FDA UDI
- FDA Product Code
- HIR FDA UDI
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1425 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
FemiScan by Bittium Biosignals , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bittium Biosignals , Ltd.
Sources (1)
- FDA UDI f91f60bc-7a24-4949-89b2-d61d9f32f87f 36 fields · synced May 30, 2026