Eu Mdd
Eu Md Class 2b
On The Market
๐บ๐ธ United States
Allurion Filler Kit
Devices (same UDI-DI)
1
Certificates
1
Countries
16
Notified Bodies
1
Basic Information
- Primary DI
- D-FD011-12QA
- Basic UDI-DI Code
- B-FD011-12QA
- Reference
- 11D-CE
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Allurion Technologies Inc.
Additional Description
Allurion Filler Kit
CND Nomenclature Codes
| Code | Description |
|---|---|
| G030601 | INTRAGASTRIC BALLOON SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G100318000006 | TรV SรD Product Service GmbH | Expired |
Available In Countries
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).
Horizontal Steam Sterilizer
Device
EU MDD
·
Eu Md Class 2b
·PROHS Equipamento Hospitalar e Serviรงos Associados S.A.·On the market·10 countries
Adacolumn
Device
EU MDD
·
Eu Md Class 2b
·JIMRO Co., Ltd.·On the market·9 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·8 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·7 countries
Sonovein
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·6 countries
Mevion S250i
Device
EU MDD
·
Eu Md Class 2b
·Mevion Medical Systems, Inc.·On the market·1 country