FDA Registration
Active
🇨🇭 Switzerland
LiNA Medical AG
Reg #: 3008693678
·
FEI: 3008693678
·
Expires 2026
Products
16
Proprietary Names
10
Establishment Types
2
Classifications
16
Registration Details
- Registration Name
- LiNA Medical AG
- Registration Number
- 3008693678
- FEI Number
- 3008693678
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Platz 3
- City
- Root D4 Luzern
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K171113
Owner / Operator
- Firm Name
- LiNA Medical AG
- Operator Number
- 10033967
- Address
- Platz 3
- City
- Root D4
- State
- Luzern
- Postal Code
- 6039
- Country
- CH
- Correspondent
- Anna Michalska
US Agent
- Business Name
- LiNA Medical INC
- Contact Name
- Nadege Boursiqout
- Address
- 1856 Corporate Dr Ste 135
- City
- Norcross
- State
- GA
- ZIP
- 30093
- Country
- US
- [email protected]
- Phone
- 770 2186801
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2018-01-26 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2010-10-22 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2011-08-24 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2026-03-30 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-09-17 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2025-04-09 |
| Culdoscope (And Accessories) | HEW | Class 2 | Obstetrics/Gynecology | No | 2010-11-05 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2025-04-09 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2018-04-09 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2013-10-24 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2010-10-22 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2020-09-07 |
| Fluid Drainage Tray | PXU | Class 1 | General, Plastic Surgery | No | 2020-09-07 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2010-11-05 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2011-08-24 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2024-09-24 |
Proprietary Names
Hook Forceps
Various Hook Forseps
(CYV-100-5; CYV-101-5) LiNA CystoVu HD
(SCP-100-1) LiNA ScopeVu
LiNA CystoVu HD Grasper (CYV-GRA-5)
45-TV LiNA McCartney tube Transvaginal tube
35-TV LiNA McCartney tube Transvaginal tube
LiNA CystoVu HD Biopsy Forceps (CYV-FCP-5)
(OP-NEE8-6) LiNA OperaScope Needle
(OP-NEE4-6) LiNA OperaScope Needle
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device