Eu Mdd
Eu Md Class 2b
On The Market
🇹🇷 Türkiye
Zaraccom
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1
Basic Information
- Primary DI
- 08698907835300
- Basic UDI-DI Code
- B-08698907835300
- Reference
- A100/01
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
Additional Description
ZARACCOM multifocal foldable hydrophobic acrylic one-piece lens (A100) is posterior chamber intraocular lens. It is manufactured bonded UV-absorber and sterile. It is designed for the replacement of an opaque natural crystalline lens of a human eye in cases of cataract removal and presbiopic surgery. The ZARACCOM multifocal foldable acrylic one-piece lens incorporates a 360-degree squared edge designed. The lens is designed to provide postoperative opportunity both near and distance vision without additional spectacle correction. This lens has a diffractive multifocal surface on the posterior side of the lens.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P030102100101 | IOLs, APHAKIC, MULTIFOCAL, SPHERICAL, HYDROPHOBIC ACRYLIC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1984-MDD-11-122 | Kiwa Belgelendirme Hizmetleri A.Ş. |
Available In Countries
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
🇬🇧 United Kingdom
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 Serviços 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