FDA Registration
Active
🇳🇱 Netherlands
PHARMCO MEDICAL BV
Reg #: 3030447506
·
FEI: 3030447506
·
Expires 2026
Products
83
Proprietary Names
10
Establishment Types
1
Classifications
83
Registration Details
- Registration Name
- PHARMCO MEDICAL BV
- Registration Number
- 3030447506
- FEI Number
- 3030447506
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ALBERT PLESMANWEG 39 X
- City
- ROTTERDAM Zuid-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K240589
Owner / Operator
- Firm Name
- PHARMCO MEDICAL BV
- Operator Number
- 10089125
- Address
- Westplein 57
- City
- ROTTERDAM
- State
- Zuid-Holland
- Postal Code
- 3016BM
- Country
- NL
- Correspondent
- John Kamen
US Agent
- Business Name
- SSPT Inc
- Contact Name
- Celia Parnicky
- Address
- 100 Se 3rd Ave Fl 10 Ste 1000
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33394
- Country
- US
- [email protected]
- Phone
- 954 2610657
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2025-08-06 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2026-05-13 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2025-12-08 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2025-08-06 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2026-02-11 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2024-04-02 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-06-02 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2026-02-27 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2026-02-27 |
| Intrauterine Tamponade Balloon | OQY | Class 2 | Obstetrics/Gynecology | No | 2026-01-17 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-02-27 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2026-02-27 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2026-01-19 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2024-04-02 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2025-08-06 |
| Stand, Instrument, Ac-Powered, Ophthalmic | HMF | Class 1 | Ophthalmic | No | 2025-05-26 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2025-08-06 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2025-09-02 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2026-05-08 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2024-07-11 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2025-07-11 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2025-09-02 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2024-07-07 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2025-08-07 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2026-01-19 |
| Exophthalmometer | HLS | Class 1 | Ophthalmic | No | 2024-04-02 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-05-23 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2024-02-21 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-02-21 |
| Set, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 2024-03-18 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2025-05-26 |
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2026-05-26 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2025-09-02 |
| Needle, Emergency Airway | BWC | Class 2 | Anesthesiology | No | 2025-09-02 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2024-04-18 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2025-07-11 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2026-02-27 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2026-01-16 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2024-05-16 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2025-03-03 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2025-02-10 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-07-18 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-09-20 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-09-20 |
| Coagulator, Laparoscopic, Unipolar (And Accessories) | HFG | Class 2 | Obstetrics/Gynecology | No | 2025-03-03 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2024-05-01 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2025-09-18 |
| Adaptor, Ureteral Catheter | EYI | Class 1 | Gastroenterology, Urology | No | 2025-08-06 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-12-17 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2024-03-18 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2026-01-19 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2024-05-01 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2026-01-19 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2024-04-02 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-05-15 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2024-07-07 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2026-03-25 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2024-05-01 |
| Point, Abrasive | EHL | Class 1 | Dental | No | 2024-02-21 |
| Dislodger, Stone, Biliary | LQR | Class 2 | Gastroenterology, Urology | No | 2025-07-11 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-09-16 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-04-02 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2026-01-19 |
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 2026-05-26 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2026-02-04 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2024-08-28 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2026-02-04 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2026-02-04 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2025-09-02 |
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2024-03-18 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2024-03-18 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2024-02-21 |
| Trocar, Gastro-Urology | FBQ | Class 2 | Gastroenterology, Urology | No | 2025-09-02 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2024-07-07 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2024-04-11 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2023-12-19 |
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2024-04-03 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2024-04-03 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2025-08-07 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2024-04-02 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2025-09-02 |
| Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) | NHC | Class 2 | Neurology | No | 2026-01-17 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2024-03-05 |
Proprietary Names
CATHETER, URETERAL OPEN END
BIOPSY NEEDLE
Catheter
TUBE, TRACH
TUBE, TRACH CUFF
CANNULA, TRACH
BECTON DICKINSON
BIOPSY INSTRUMENT
VIROSAFE FLUID TRAP
STENT, DRAINS, DILATORS
Establishment Types
Export Device to the United States But Perform No Other Operation on Device