FDA Registration
Active
🇪🇸 Spain
CYDONIA PHARMA SL
Reg #: 3011088743
·
FEI: 3011088743
·
Expires 2026
Products
33
Proprietary Names
20
Establishment Types
1
Classifications
33
Registration Details
- Registration Name
- CYDONIA PHARMA SL
- Registration Number
- 3011088743
- FEI Number
- 3011088743
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- C/Conde Altea 54 p1
- City
- valencia
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K071785
Owner / Operator
- Firm Name
- Cydonia Pharma SL
- Operator Number
- 10052225
- Address
- C/Conde Altea 54 p1
- City
- valencia
- State
- ES-V
- Postal Code
- 46005
- Country
- ES
- Correspondent
- Victor Villalba
US Agent
- Business Name
- TAS
- Contact Name
- Zvi Sklarz
- Address
- 500 Davistown Rd
- City
- Blackwood
- State
- NJ
- ZIP
- 08012
- Country
- US
- [email protected]
- Phone
- 347 4034107
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2022-08-08 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2016-10-05 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2016-10-05 |
| Allergen And Vaccine Delivery Needles | SCL | Class 2 | General Hospital | No | 2025-04-23 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2023-06-07 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2024-10-31 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2021-11-04 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2023-01-02 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2017-03-03 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2024-12-02 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2024-12-02 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2024-06-24 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2016-08-23 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2019-12-20 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2016-08-24 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2026-06-05 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2023-11-15 |
| System, Transport, Aerobic | JTW | Class 1 | Microbiology | No | 2018-01-03 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2026-04-28 |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | Class 2 | Ear, Nose, Throat | No | 2026-04-28 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2026-04-28 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2022-02-08 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2016-08-23 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2023-02-22 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2022-11-24 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-04-09 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2025-04-23 |
| Hemodialysis Catheter Luer End Cap | PEH | Class 2 | Gastroenterology, Urology | No | 2024-10-31 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2024-10-31 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2022-08-08 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2024-07-17 |
| Balloon Aortic Valvuloplasty | OZT | Class 2 | Cardiovascular | No | 2024-10-31 |
| Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | OMZ | Class 2 | Cardiovascular | No | 2024-10-31 |
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
BD Syringe; Disposable
BD Luer-Lok Access Device
BD Blood Collection Set
BD Safety-Lok Blood Collection Set
Angiocath IV Catheter; Autoguard IV Catheter; Insyte Autoguard IV Catheter
Nexiva IV Catheter
Biogel PI Micro surgical glove
Monoject Insulin Safety Syringes; 1/2 ML, 1 ML
Monoject 1 mL Tuberculin Safety Syringe with Needle
Establishment Types
Export Device to the United States But Perform No Other Operation on Device