FDA Registration
Active
🇵🇱 Poland
STERISERVICE SP. Z O.O.
Reg #: 3015972753
·
FEI: 3015972753
·
Expires 2026
Products
23
Proprietary Names
58
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- STERISERVICE SP. Z O.O.
- Registration Number
- 3015972753
- FEI Number
- 3015972753
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ul. Ekonomiczna 5
- City
- Czestochowa Slaskie
- Country
- PL
Owner / Operator
- Firm Name
- Steriservice Sp. z o.o.
- Operator Number
- 10061367
- Address
- Fabryczna 13/1
- City
- Zielona Góra
- State
- Lubuskie
- Postal Code
- 65-410
- Country
- PL
- Correspondent
- Bartosz Rogacki
US Agent
- Business Name
- Medical Device Academy Incorporated
- Contact Name
- Robert Packard
- Address
- 345 Lincoln Hill Rd
- City
- Cuttingsville
- State
- VT
- ZIP
- 05738
- Country
- US
- [email protected]
- Phone
- 802 2581881
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2019-10-11 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2026-04-20 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2019-10-14 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2026-01-30 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-01-30 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2026-01-30 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-09-25 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2026-01-29 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-07-24 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2025-07-24 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2019-10-14 |
| Tubing And Tubing/Filter Fits | NVT | Class 1 | Obstetrics/Gynecology | No | 2019-10-14 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2022-01-05 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2023-09-28 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2019-10-14 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 2019-10-14 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2023-09-28 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2023-09-28 |
| Tie, Dialysis | FKE | Class 1 | Gastroenterology, Urology | No | 2019-10-11 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2019-10-14 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2026-01-30 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2019-10-14 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2026-01-29 |
Proprietary Names
LiNA SkinHook, small blunt, dual pack
LiNA SkinHook, smal, angled, extra sharp, dual pack
LiNA SkinHook, large blunt, dual pack
LiNA SeaStar, SS model
LiNA SeaStar, VS model
LiNA SeaStar, SL model
LiNA SeaStar, squared model
LiNA SkinHook, small sharp, dual pack
LiNA SeaStar, VV model
LiNA SeaStar, VL model
C-CAT Anesthesia Catheter
LiNA OperaScope with HDMI cable
LiNA OperaScope Needle (OP-NEE4-6)
LiNA OperaScope Needle (OP-NEE8-6)
LiNA PowerBlade Plus
LiNA PowerBlade Plus HC
LiNA CystoVu HD Grasper
LiNA CystoVu HD
Disposable needle guide for 9029
Biopsy guide for 8818
Endfire biopsy guide for 8818
Biplane biopsy guide for 8818
Dual biopsy guide for 8818
LiNA OperaScope for hysteroscopy and cystocopy with HDMI cable & LCD
956-624 SafePICO70 23Gx25 mm
956-616 SafePICO Self-fill 23Gx25 mm
956-612 SafePICO Self-fill 23Gx16 mm
956-610 SafePICO Self-fill
956-609 SafePICO70 23Gx16 mm
956-608 SafePICO70 22Gx32 mm
956-613 SafePICO Self-fill 22Gx25 mm
956-615 SafePICO Self-fill 23Gx16 mm
956-623 SafePICO Self-fill 25Gx16 mm
956-614 SafePICO Self-fill 22Gx32 mm
LiNA OperaScope Scissors
LiNA OperaScope Angled Lasso
LiNA OperaScope Lasso
LiNA OperaScope Rat Tooth Alligator Grasper for hysteroscopy and cystoscopy
LiNA OperaScope Biopsy Forceps for hysteroscopy and cystoscopy
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
LiNA Bipolar Loop (BL-160)
LiNA Bipolar Loop (BL-200)
LiNA Bipolar Loop (BL-240)
LiNA OperaScope Angled Lasso (OP-LAS10A-3)
LiNA OperaScope Lasso (OP-LAS16-3)
LiNA OperaScope Angled Lasso (OP-LAS16A-3)
LiNA OperaScope Lasso (OP-LAS10-3)
LiNA CystoVu HD Biopsy Forceps
956-547 PICO 70 25Gx16 mm
956-525 PICO 70 22Gx35 mm
956-522 PICO 70 22Gx25 mm
956-518 PICO70
Needle Guide UA1345
Needle Guide for 8824
Needle Guide for 5C1E
Needle Guide UA1338
Needle Guide UA1346
Needle Guide for 8815
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)