Zaraccom
Basic Information
- Primary DI
- 08680738602473
- Basic UDI-DI Code
- B-08680738602473
- Reference
- AS60125P/01
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
Additional Description
ZARACCOM Foldable Hydrophobic Acrylic Aspheric Intraocular Lenses are designed as an aberration free optic device with aspheric anterior surface to replace with the crystalline lens in the human eye and for implantation behind the iris, in the capsular bag. The lenses are consisted of hydrophobic acrylic, various polymeric materials and were manufactured bonded UV-absorber, sterile, monobloc, aspheric as posterior chamber lenses. Models AS60125P are offered preloaded on an existing cartridge-injector system. These products are intended to be placed inside the eye to guide the placement of the intraocular lens during surgery and are discarded after placement is complete. The intraocular lens and cartridge and injector system (preloaded IOL) are disposable and sterile.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P030102090201 | IOLs, APHAKIC, MONOFOCAL, ASPHERIC, 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
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).