Clinico Medical Sp. z o.o.

FDA Device Registration & Listing · Blonie/Miekinia Dolnoslaskie, PL · Registration 3008810357

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008810357
FEI Number
3008810357
Entity Name
Clinico Medical Sp. z o.o.
City/State/Country
Blonie/Miekinia Dolnoslaskie, PL
Establishment Address
Blonie k/ Wroclawia, ul. Roberta Kocha 1, Blonie/Miekinia Dolnoslaskie 55-330, PL
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Fresenius Kabi AG (Owner Number: 9027285)
Owner / Operator Contact Address
Else-Kroner-Str. 1, 61352 Bad Homburg, DE-NOTA NONE, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Volumat Line CATSmart System CATSmart CATSmart Non Invasive Tubing Volumat Line 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-12-10
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2016-09-22
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2020-01-24
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2020-01-24
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2022-06-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-02-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2015-01-24
KSS Supplies, Blood-Bank Hematology Class 1 864.9050 2020-07-01
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-05-24
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2022-11-28
FRN Pump, Infusion General Hospital Class 2 880.5725 2013-05-23
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2025-11-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-05-24
LZG Pump, Infusion, Insulin General Hospital Class 2 880.5725 2013-05-24
NDC Calculator, Drug Dose Anesthesiology Class 2 868.1890 2013-05-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-11-17
BSB Warmer, Blood, Non-Electromagnetic Radiation Hematology Class 2 864.9205 2024-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

Rhoda Lynn Valera Email: rhoda.valera@fresenius-kabi.com Phone: (847) 5502929

Related Public Records

Same Entity

Fresenius Kabi AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014732157 Fresenius Kabi USA, LLC North Andover, MA, US
3004634229 FRESENIUS HEMOCARE GMBH Friedberg Hesse, DE
9611902 Fenwal France S.A.S. Lacs Indre, FR
9681819 FRESENIUS KABI DEUTSCHLAND GMBH BAD HERSFELD Hesse, DE
3005778453 FRESENIUS KABI WARRENDALE WARRENDALE, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008810357. Last updated year: 2026. Please use registration number 3008810357 when referencing this establishment in official correspondence.
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