FDA Registration
Active
🇨🇭 Switzerland
SDI SURGICAL DEVICE INTERNATIONAL GMBH
Reg #: 3006234591
·
FEI: 3006234591
·
Expires 2026
Products
9
Proprietary Names
3
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- SDI SURGICAL DEVICE INTERNATIONAL GMBH
- Registration Number
- 3006234591
- FEI Number
- 3006234591
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Mattenstrasse 11
- City
- Bruegg Bern
- Country
- CH
Owner / Operator
- Firm Name
- SDI SURGICAL DEVICE INTERNATIONAL GMBH
- Operator Number
- 9096119
- Address
- 1 Helmstrasse, --
- City
- Port
- State
- CH-NOTA
- Postal Code
- 2562
- Country
- CH
- Correspondent
- MEYER - THOMAS
US Agent
- Business Name
- Diatome US
- Contact Name
- Stacie Kirsch
- Address
- 314 W Broad St Ste 203
- City
- Quakertown
- State
- PA
- ZIP
- 18951
- Country
- US
- [email protected]
- Phone
- 215 4128390
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2009-04-30 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2025-07-22 |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | Class 1 | Ophthalmic | No | 2025-07-22 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2025-05-26 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2025-07-22 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2025-07-22 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2025-05-26 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2012-11-19 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2006-12-29 |
Proprietary Names
Scleral marker Toric
Katena
Ocular Marker
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)