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
Phone
720 9625412

Products

Device Name Product Code
Device, Analysis, Anterior Segment MXK
Ophthalmic Femtosecond Laser OOE
Powered Laser Surgical Instrument GEX
Keratome, Ac-Powered HNO
Trephine, Manual, Ophthalmic HRH
Laser, Ophthalmic HQF

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