Carl Zeiss Meditec AG
DE-MF-000007732 · Germany · Jena
Carl Zeiss Meditec AG is registered in the European database on medical devices as a manufacturer, with 4 860 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 4 616 |
|---|---|
| Class IIa | 226 |
| Class I | 18 |
Most frequent device types declared: SL 115 CLassic, SL 120, 130, SL 220, RESIGHT 500, RESIGHT 700, RESIGHT metal tray, MACULA LENS, WIDE-ANGLE LENS, ULTRA WIDE-ANGLE LENS, OPMI Lumera 700 floor stand, OPMI Lumera 700 ceiling mount, ARTEVO 800, VISULAS green.
Among these devices, 4 688 are declared sterile, 2 559 implantable, 4 reusable, 100 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CARL ZEISS MEDITEC INC (US) · FDA 2918630 |
| Devices in EUDAMED | 4 860 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000322419 | issued | 2031-07-07 |
1000319402 | supplemented | 2027-01-05 |