Eu Mdd
Eu Md Class 1
No Longer On The Market
šµš± Poland
Bifenxe
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-125EN-15F
- Basic UDI-DI Code
- B-125EN-15F
- Reference
- 125EN-1
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- No Longer On The Market
- Manufacturer
- GLOBAL PHARMA CM S.A
Additional Description
The medical device can be used supportively in the treatment of bacterial infections of the mouth and throat, discomfort caused by increased breathing through the mouth e.g. during nasal obstructions, dryness in the throat, scratching in the throat, burning sensation during swallowing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q030199 | NASOPHARYNGEAL DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | AC090 MD/2136/5302/2021 | TUV NORD Polska Sp. z o.o |
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