Thermablate EAS
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Basic Information
- Primary DI
- 05392000074101
- Basic UDI-DI Code
- B-05392000074101
- Reference
- 21004
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Idoman Teoranta
Additional Description
A device in the form of a thin tube with an inflatable balloon at its distal tip intended to be used to provide heat 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 designed to be attached to a hand-held control unit in which a fluid medium (e.g., glycerin) is heated before being forced into the catheter balloon under pressure to compress against the uterine wall and circulate within for homogenous heat distribution. This is a single-use device.
CND Nomenclature Codes
| Code | Description |
|---|---|
| U080101 | CATHETERS FOR ENDOMETRIAL ABLATION |
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).