Haag-Streit AG
CH-MF-000020981 · Switzerland · Köniz
Haag-Streit AG is registered in the European database on medical devices as a manufacturer, with 139 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 137 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: AT 870, AT 900 BQ, AT 900 D BQ, AT 900 D R, AT 900 D T.
Among these devices, 1 are declared sterile, 50 active, 16 with a measuring function.
Authorised representative in the Union: Haag-Streit Deutschland GmbH.
Devices declared under this manufacturer
- Applanation Tonometer AT 900 model BQ
- Assistant scope w. mag. changer 5-step
- Beam Splitter T
- Connector Box CB01
- Contact Lens 901
- Contact Lens 903
- Contact Lens CGAL
- Foot Switch EF 5000
- HS Hi-R NEO 900A
- HS MIOS 5
- Headrest HR-E
- Headrest HR-M
Showing 12 of 139 declared devices.
Catalogue references include 1023640, 1400273, 1400291, 1400421, 1420150, 1420193.
European nomenclature codes declared: Z12120108, Z1201118099, Q0299, Z12120102, Z12120122, Z12011101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HAAG-STREIT AG (CH) · FDA 1000176188 |
| Devices in EUDAMED | 139 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 139 |
|---|---|
| Found in the U.S. device database | 78 |
| Share | 56.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HAAG-STREIT, AG |
What it holds in Canada
| Licences on record | 10 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 10 |
| First licensed | 2004-08-03 |
Licence types: Device Family (5), Single Device (3), Device Group Family (1), System (1).
Licensed under: HAAG-STREIT MEASURING PRISMS, HAAG-STREIT LASER CONTACT GLASSES, HAAG-STREIT DIAGNOSTIC CONTACT GLASSES, BIOMETER LS 900, APPLANATION TONOMETERS, PERIMETER OCTOPUS 900.
North American profile: Both markets. Haag-Streit AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
170775963 | issued | 2027-07-06 |
170775962 | issued | 2027-07-06 |
1000313788 | supplemented | 2027-07-06 |