FDA Registration
Active
🇵🇱 Poland
LiNA Medical Polska sp. z o.o
Reg #: 3007699067
·
FEI: 3007699067
·
Expires 2026
Products
16
Proprietary Names
6
Establishment Types
2
Classifications
16
Registration Details
- Registration Name
- LiNA Medical Polska sp. z o.o
- Registration Number
- 3007699067
- FEI Number
- 3007699067
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ul. Rolna 8A, Sady
- City
- Tarnowo Podgorne Wielkopolskie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K240227
Owner / Operator
- Firm Name
- LINA MEDICAL APS
- Operator Number
- 9044000
- Address
- FORMERVANGEN 5, --
- City
- GLOSTRUP
- State
- Hovedstaden
- Postal Code
- 2600
- Country
- DK
- 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 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2025-04-09 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2025-04-09 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2013-07-29 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2013-10-23 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2020-08-20 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2007-12-03 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-09-11 |
| Fluid Drainage Tray | PXU | Class 1 | General, Plastic Surgery | No | 2020-08-20 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2022-09-12 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2011-05-05 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2006-12-29 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2006-12-29 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2018-04-09 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2006-12-29 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2013-10-23 |
Proprietary Names
LiNA CystoVu HD Grasper (CYV-GRA-5)
LiNA CystoVu HD Biopsy Forceps (CYV-FCP-5)
LiNA CystoVu HD (CYV-100-5; CYV-101-5)
LiNA ScopeVu (SCP-100-1)
Skater Fix (8199)
LiNA SeaStar, SS model (4000-S-SS)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device