Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-131EN-34L
- Basic UDI-DI Code
- B-131EN-34L
- Reference
- 131EN-3
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- GLOBAL PHARMA CM S.A
Additional Description
The medical device can be used supportively when relieving discomfort caused by minor oral lesions such as: aphthous stomatitis, aphthous ulcers, changes caused by wearing orthodontic appliances, improperly fitted dentures.
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 |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDD).
Pedi-Scoliometer
Device
EU MDD
·
Eu Md Class 1
·Pedihealth Oy·On the market
MEDICAL PLASTERS - OTHER
Device
EU MDD
·
Eu Md Class 1
·FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)·On the market
Sensotrend Connect
Device
EU MDD
·
Eu Md Class 1
·Sensotrend Oy·On the market
Electronic anti lice comb
Device
EU MDD
·
Eu Md Class 1
·Nexmed Technology Co.,Ltd.·On the market
GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - CONSUMABLES
Device
EU MDD
·
Eu Md Class 1
·Casmed International Ltd.·On the market·5 countries
GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - CONSUMABLES
Device
EU MDD
·
Eu Md Class 1
·Casmed International Ltd.·On the market·5 countries