Eu Mdd
Eu Md Class 1
On The Market
🇰🇷 South Korea
Earloon Eustachian Tube Dilation System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800026513308
- Basic UDI-DI Code
- B-08800026513308
- Reference
- 12406
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Genoss Co., Ltd
Additional Description
The EarloonTM Eustachian Tube Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 18 and older.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q030201 | EPISTAXIS CATHETERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 2195-MED-1821101 | Szutest Uygunluk Değerlendirme A.Ş. |
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