FDA Registration
Active
🇨🇭 Switzerland
HAAG-STREIT AG
Reg #: 1000176188
·
FEI: 1000176188
·
Expires 2026
Products
10
Proprietary Names
21
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- HAAG-STREIT AG
- Registration Number
- 1000176188
- FEI Number
- 1000176188
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GARTENSTADTSTRASSE 10
- City
- KOENIZ Bern
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K051103
Owner / Operator
- Firm Name
- HAAG-STREIT HOLDING
- Operator Number
- 8031066
- Address
- GARTENSTADTSTRASSE 10, --
- City
- KOENIZ
- State
- Bern
- Postal Code
- CH-3098
- Country
- CH
- Correspondent
- Thomas Diesch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 1978-04-25 |
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2003-12-26 |
| Device, Storage, Images, Ophthalmic | NFF | Class 1 | Radiology | No | 2012-12-03 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2011-03-29 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2009-11-03 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2007-12-12 |
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2014-10-28 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 1997-07-24 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2014-12-16 |
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | PUE | Class 2 | Ophthalmic | No | 2020-11-10 |
Proprietary Names
HS Surgical Microscopes, Carrier and Accessories: Hi-R NEO 900(;900A) / FS 2-25 / Accessories
Metis 900
Metis 3D Digital Heads-Up Module
HS MIOS 5
Stery Cup
Accessory
Haag-Streit Contact Glasses
Lenstar Myopia APS
EyeSuite Myopia + AMMC Software
EyeSuite Myopia Standalone
Eyesuite Myopia
Phoropter Refractor 900 Prism
Phoropter Refractor 900
C.MOR HD; C.MOR HD ³
GOLDMAN MANUAL TONOMETER
APPLANATION TONOMETER AT 900 BQ
APPLANATION TONOMETER AT 870
APPLANATION TONOMETER AT 900 T
APPLANATION TONOMETER AT 900 R
Elara 900 VS
Elara 900
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device