Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011088743

FEI Number

3011088743

Entity Name

CYDONIA PHARMA SL

City/State/Country

valencia, ES

Establishment Address

C/Conde Altea 54 p1, valencia 46005, ES

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Cydonia Pharma SL (Owner Number: 10052225)

Owner / Operator Contact Address

C/Conde Altea 54 p1, valencia, ES-V 46005, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K050600

PMA Number

N/A

All Registered Proprietary Names

BD Push Button Blood Collection Set Blood Collection Tube with Hemogard CARDINAL GLOVE, SURG LF PF MICRO BD BLOOD LANCET; MULTIPLE LANCETS; MICRO-FINE LANCETS Q-Syte Luer Access Device Safetyglide Syringe; SYRINGE, ANTISTICK Protectiv; Protectiv Plus; Jelco; Cathlon; Optiva; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS BD Blunt Filter Needle BD SafetyGlide Needle Urine Collecting Conical Tube BD Blunt Filter Needle; BD Visitec Fluid Filter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-08-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2016-10-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-10-05
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2025-04-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2017-04-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2023-06-07
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2024-10-31
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2021-11-04
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-06-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-02-27
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-01-02
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2017-03-03
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-12-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-12-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-02-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-02-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-10-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-11-04
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-06-24
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2016-08-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-02-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2024-01-16
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2019-12-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-12-22
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2016-08-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-06-30
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2026-06-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-17
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-07-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-02-22
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2024-08-08
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2021-11-04
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2023-11-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-08-04
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-12-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-12-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-11-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-11-15
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2018-01-03
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2026-04-28
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2026-04-28
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2026-04-28
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2022-02-08
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2016-08-23
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2023-02-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-02-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-03-23

Official Correspondent

Victor Villalba

US Agent Details

Zvi Sklarz Business: TAS Email: zvi@tasmedical.com Phone: (347) 4034107

Related Public Records

Same Entity

Cydonia Pharma SL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011088743. Last updated year: 2026. Please use registration number 3011088743 when referencing this establishment in official correspondence.