FDA Registration
Active
🇵🇱 Poland
Clinico Medical Sp. z o.o.
Reg #: 3008810357
·
FEI: 3008810357
·
Expires 2026
Products
15
Proprietary Names
26
Establishment Types
3
Classifications
15
Registration Details
- Registration Name
- Clinico Medical Sp. z o.o.
- Registration Number
- 3008810357
- FEI Number
- 3008810357
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Blonie k/ Wroclawia, ul. Roberta Kocha 1
- City
- Blonie/Miekinia Dolnoslaskie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K220301
Owner / Operator
- Firm Name
- Fresenius Kabi AG
- Operator Number
- 9027285
- Address
- Else-Kroner-Str. 1
- City
- 61352 Bad Homburg
- State
- DE-NOTA
- Postal Code
- NONE
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2024-12-10 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2016-09-22 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2022-06-21 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2015-01-24 |
| Supplies, Blood-Bank | KSS | Class 1 | Hematology | No | 2020-07-01 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2022-11-28 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2013-05-23 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2025-11-26 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2013-05-24 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2013-05-24 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2013-05-24 |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | Class 2 | Hematology | No | 2024-09-17 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2022-11-16 |
| Hematocrit, Tube, Rack, Sealer, Holder | GHY | Class 2 | Hematology | No | 2007-11-16 |
| Device, Blood Mixing And Blood Weighing | KSQ | Class 1 | Hematology | No | 2007-11-16 |
Proprietary Names
Volumat Line
CATSmart System
CATSmart
Non Invasive Tubing
AbbVie J
CompoMat G5 Plus and CompoMaster Net G5 Plus
Accu-Chek Rapid-D
Transfer Set
VOLUMAT MC AGILIA
VOLUMAT LINES
Tubing Set
Endomat Select
Accu-Chek Spirit 3.15 ml Cartridge system
K-Zero Needleless Connector
ASTOTUBE
freeflex+ Transfer Adapter
AbbVie PEG
Composeal Universal
Composeal Mobilea
HemoSeal
CompoSeal Mobilea II
DONATION MASTER NT
HEMOLIGHT PLUS
COMPOGUARD
DONATIONMASTER ADVANCE SOFTWARE
COMPOGUARD ADVANCE
Establishment Types
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)