Thermablate EAS
Basic Information
- Primary DI
- 05392000074118
- Basic UDI-DI Code
- B-05392000074118
- Reference
- 22001
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Idoman Teoranta
Additional Description
Supplied as Treatment Control Unit Kit Ref:22101. A hand-held, electrically-powered device designed to produce and regulate heat in a circulating fluid for ablation (typically at a temperature of approximately 150ยฐC) of the interior lining of the uterus (endometrium) for the treatment of dysfunctional uterine bleeding (menorrhagia). It is intended to be used with a disposable catheter component which circulates the heated fluid. It typically provides computerized control of treatment settings, including time, pressure, and temperature, and consists of an LCD user-interface to display treatment stage information and controls to initiate treatment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12080201 | ENDOMETRIAL ABLATION EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | GB19/964798 | SGS Belgium NV | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).