FDA Registration
Active
🇨🇭 Switzerland
ZIEMER OPHTHALMIC SYSTEMS AG
Reg #: 3004858034
·
FEI: 3004858034
·
Expires 2026
Products
6
Proprietary Names
19
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- ZIEMER OPHTHALMIC SYSTEMS AG
- Registration Number
- 3004858034
- FEI Number
- 3004858034
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ALLMENDSTRASSE 11
- City
- PORT Bern
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K051940
Owner / Operator
- Firm Name
- ZIEMER OPHTHALMIC SYSTEMS AG
- Operator Number
- 9067737
- Address
- Allmendstrasse 11, --
- City
- PORT
- State
- CH-NOTA
- Postal Code
- CH - 2562
- Country
- CH
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- KEVIN WALLS
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Analysis, Anterior Segment | MXK | Class 2 | Ophthalmic | No | 2005-11-29 |
| Ophthalmic Femtosecond Laser | OOE | Class 2 | Ophthalmic | No | 2022-06-09 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2007-10-23 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2007-10-23 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2015-10-11 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2012-10-23 |
Proprietary Names
Galilei G4
Procedure Packs for Corneal Surgery
FEMTO Z8 NEO
Procedure Packs for Cataract Surgery
Procedure Packs for Corneal Surgery Liquid
Procedure Packs
FEMTO Crystal Line
Procedure Packs LCS
Intershield for LCS
Artificial Anterior Chamber Base Set (AAC) for Femto LDV
Artificial Chamber Interface
Galilei G6
FEMTO LDV Z4
FEMTO LDV Z2
FEMTO LDV Z6
Procedure Packs Corneal Surgery
Procedure Packs LASIK
Procedure Packs Advanced Corneal Surgery
Femto LDV Z8
Establishment Types
Manufacture Medical Device