Eu Mdd
Eu Md Class 2b
On The Market
๐ฎ๐ช Ireland
Thermablate EAS
Devices (same UDI-DI)
1
Certificates
1
Countries
17
Notified Bodies
1
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
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ธ๐ช Sweden
๐ฌ๐ง United Kingdom
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