Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030447506

FEI Number

3030447506

Entity Name

PHARMCO MEDICAL BV

City/State/Country

ROTTERDAM Zuid-Holland, NL

Establishment Address

ALBERT PLESMANWEG 39 X, ROTTERDAM Zuid-Holland 90477456, NL

Establishment Type(s)

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

Owner / Operator

PHARMCO MEDICAL BV (Owner Number: 10089125)

Owner / Operator Contact Address

Westplein 57, ROTTERDAM, NL-ZH 3016BM, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K961225

PMA Number

N/A

All Registered Proprietary Names

CATHETER, URETERAL OPEN END BIOPSY NEEDLE Catheter TUBE, TRACH TUBE, TRACH CUFF CANNULA, TRACH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2025-08-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-05-13
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2025-12-08
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-08-06
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2026-02-11
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2024-04-02
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-06-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-02-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-02-27
OQY	Intrauterine Tamponade Balloon	Obstetrics/Gynecology	Class 2	884.4530	2026-01-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-02-27
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2026-02-27
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2026-01-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-04-02
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-08-06
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2025-05-26
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-08-06
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2025-09-02
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2026-05-08
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2024-07-11
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2025-07-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2025-09-02
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2024-07-07
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2025-08-07
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2026-01-19
HLS	Exophthalmometer	Ophthalmic	Class 1	886.1270	2024-04-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-05-23
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-02-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-02-21
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2025-03-03
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2024-03-18
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-05-26
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2026-05-26
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2025-09-02
BWC	Needle, Emergency Airway	Anesthesiology	Class 2	868.5090	2025-09-02
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-04-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-05-06
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-07-11
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2026-02-27
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2026-01-16
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-05-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-03-03
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2025-03-03
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-02-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-07-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-07-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-07-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-06-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-06-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-09-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-09-20
HFG	Coagulator, Laparoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2025-03-03
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2024-07-07
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-05-01
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-05-01
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-07-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-03-20
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2025-09-18
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2025-09-02
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2025-08-06
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-04-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-12-17
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2024-03-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-03-28
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-01-19
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2026-05-20
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2024-05-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-05-01
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-01-19
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-04-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-03-05
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-05-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-05-15
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-05-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-05-23
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2024-07-07
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-06-02
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-06-02
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-06-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-02-10
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2026-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-05-01
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2024-05-01
EHL	Point, Abrasive	Dental	Class 1	872.6010	2024-02-21
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2025-07-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-09-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-02-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-04-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-04-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-04-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-01-19
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-01-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-05-13
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2026-05-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-02-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-07
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2026-05-26
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2025-07-11
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2025-07-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2026-02-04
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2024-08-28
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2026-02-04
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2026-02-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-03-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-03-05

Official Correspondent

John Kamen

US Agent Details

Celia Parnicky Business: SSPT Inc Email: manager@airshiptrading.com Phone: (954) 2610657

Related Public Records

Same Entity

PHARMCO MEDICAL BV

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

View Entity Profile →

Related 510(k) Records

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K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
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K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030447506. Last updated year: 2026. Please use registration number 3030447506 when referencing this establishment in official correspondence.