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: ARTEVO 750, ARTEVO 850, Endoprobe 23 gauge, angled, sterile (UoS), MACULA LENS, WIDE-ANGLE LENS, ULTRA WIDE-ANGLE LENS, RESIGHT 500, RESIGHT 700, RESIGHT metal tray, SL 115 CLassic, SL 120, 130, SL 220.
Among these devices, 4 688 are declared sterile, 2 559 implantable, 4 reusable, 100 active.
Devices declared under this manufacturer
- 20G PHACO TIP,15°
- ARTEVO 750/850
- AT LISA 809MP
- AT LISA tri toric 939M
- AT LISA tri toric 939MP
- AT TORBI 709M
- AT TORBI 709MP
- CALLISTO eye Panel PC
- CT LUCIA 202
- DRAINAGE BAG
- I/A HANDPIECE, 21G ANGLED 45°
- Treatment Pack
Showing 12 of 4 860 declared devices.
Catalogue references include 000000-2560-688, 303060-0054-000, 303060-0203-000, 303071-9090-000, 326082-0000-000, 6649.
European nomenclature codes declared: P030102090302, P030102100302, Z1212020785, P030102100202, P030102090101, Z11010185.
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 |
Device-level evidence
| Devices with a numeric GTIN | 4 860 |
|---|---|
| Found in the U.S. device database | 175 |
| Share | 3.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CARL ZEISS MEDITEC INC. |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| First licensed | 1999-06-29 |
Licence types: Device Family (2), System (2), Single Device (1).
Licensed under: HUMPHREY FIELD ANALYSER, CIRRUS HD-OCT, ATLAS 9000 CORNEAL TOPOGRAPHY SYSTEM, PLEX ELITE 9000, CLARUS.
North American profile: Both markets. Carl Zeiss Meditec AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000322419 | issued | 2031-07-07 |
1000319402 | supplemented | 2027-01-05 |