SIE AG, Surgical Instrument Engineering
CH-MF-000025018 · Switzerland · Port
SIE AG, Surgical Instrument Engineering is registered in the European database on medical devices as a manufacturer, with 62 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 57 |
|---|---|
| Class IIb | 5 |
Most frequent device types declared: Artificial Anterior Chamber (AAC) Product Range, FEMTO LDV Z2, FEMTO LDV Z4, FEMTO LDV Z6, FEMTO LDV Z8, FEMTO Z8 NEO., Procedure Pack Product Range.
Among these devices, 53 are declared sterile, 5 active.
Authorised representative in the Union: Ziemer Ophthalmology (DE) GmbH.
Devices declared under this manufacturer
- Disposable Suction Tubing
- FEMTO LDV Z2
- LCS InterShields d200 µm
- LCS InterShields d420 µm
- LCS InterShields d450 µm
- LCS Suction Ring Mounting Set 9.5 mm
- Procedure Pack for Cataract Surgery SLIM
- Suction Ring Mounting Set 100 µm, 10.0 mm
- Suction Ring Mounting Set 110 µm, 9.0 mm
- Suction Ring Mounting Set 140 µm, 10.0 mm
- Suction Ring Mounting Set for Advanced Corneal Surgery 8.5mm
- Suction Ring Mounting Set for Corneal Surgery 10.0 mm
Showing 12 of 62 declared devices.
Catalogue references include 510.003.002, 510.700.201, 510.701.270, 510.710.121, 510.710.140, 510.710.154.
European nomenclature codes declared: V0599, Q020199, L170401.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 62 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 62 |
|---|---|
| Found in the U.S. device database | 24 |
| Share | 38.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SIE AG SURGICAL INSTRUMENT ENGINEERING AG |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 2 |
| First licensed | 2007-12-31 |
Licence types: System (2).
Licensed under: FEMTO LDV Z8, FEMTO LDV FEMTOSECOND SURGICAL LASER.
North American profile: Canada only. SIE AG, Surgical Instrument Engineering holds a Canadian licence but was not found in the U.S. register.