PALM MEDICAL INTERNATIONAL BV

FDA Device Registration & Listing · Buggenhout Oost-Vlaanderen, BE · Registration 3030626857

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
3030626857
FEI Number
3030626857
Entity Name
PALM MEDICAL INTERNATIONAL BV
City/State/Country
Buggenhout Oost-Vlaanderen, BE
Establishment Address
Broekstraat 65, Buggenhout Oost-Vlaanderen 9255, BE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
PALM MEDICAL INTERNATIONAL BV (Owner Number: 10090320)
Owner / Operator Contact Address
Broekstraat 65, Buggenhout, BE-VOV 9255, BE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Tubes, vials, systems, serum separators, blood collection Syringe, piston Peritoneal, drainage catheter for refractory ascites, long-term indwelling Tube tracheostomy and tube cuff Peritoneal, drainage catheter for refractory ascites, long-term indwelling steridrape Needle, conduction, anesthetic (w/wo introducer) RETRACTOR Speculum, vaginal, nonmetal pneumoperitoneum needle APPARATUS, SUCTION, PATIENT CARE Catheter, intravascular, therapeutic, short-term less than 30 days Syringe, antistick Tube tracheostomy and tube cuff Syringe, piston CONTAINER, LIQUID MEDICATION, GRADUATED Anesthesia conduction kit Catheter, intravascular, therapeutic, short-term less than 30 days Needle, hypodermic, single lumen Needele, hypodermic, single lumen Tubes, vials, systems, serum separators, blood collection Set, administration, intravascual Thermometer, electronic, clinical Catheter, intravascular, therapeutic, short-term less than 30 days Anesthesia conduction kit Needele, hypodermic, single lumen Anti fog solution and accessories, endoscopy GCJ - Laparoscope, general & plastic surgery Indicator, biological sterilization process Set, administration, intravascual Needele, hypodermic, single lumen Catheter, intravascular, therapeutic, short-term less than 30 days Set, i.V. Fluid transfer Needle, conduction, anesthetic (w/wo introducer) Catheter, intravascular, therapeutic, short-term less than 30 days CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE Biopsy needle Set, administration, intravascular

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2026-04-16
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2024-05-10
FMF Syringe, Piston General Hospital Class 2 880.5860 2026-04-16
MEG Syringe, Antistick General Hospital Class 2 880.5860 2024-06-05
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2026-04-16
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2024-04-15
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2026-04-16
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2026-04-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-05-10
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2025-06-26
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2026-04-16
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2026-02-13
GAD Retractor General, Plastic Surgery Class 1 878.4800 2026-04-16
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2024-04-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-04-15
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-04-15
BSB Warmer, Blood, Non-Electromagnetic Radiation Hematology Class 2 864.9205 2024-06-05
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-12-26
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2026-04-16
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2024-04-05
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2024-06-05
FHO Pneumoperitoneum Needle Gastroenterology, Urology Class 2 876.1500 2026-04-16
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-06-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-06-12
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2026-06-12
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2026-04-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-05-10
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2026-04-16
IWZ Film, Radiographic Radiology Class 1 892.1840 2024-08-19
MEG Syringe, Antistick General Hospital Class 2 880.5860 2026-04-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2026-04-16
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2026-04-16
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2026-06-12
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2026-01-30
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2026-04-16
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2026-04-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2026-04-16
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2026-04-16
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2026-04-16
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2024-04-05
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2026-04-16
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2024-04-15
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2026-04-16
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2026-06-12
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2026-04-16
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-04-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-01-27
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2026-04-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-04-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2026-04-16
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2025-04-04
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2026-04-16
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2024-04-15
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-06-05
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2026-04-16
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2024-04-15
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2026-04-16
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2026-04-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2026-04-16
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-04-15
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2026-06-12
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2024-04-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-12-17
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2026-04-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-04-16
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2026-04-16
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2026-04-16
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2026-04-16
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-03-12
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2026-04-16
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-06-05
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2024-04-15
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2026-04-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-02-04
KEW Slides, Microscope Pathology Class 1 864.3010 2025-11-20
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2026-04-16
KDW Container, Specimen Mailer And Storage, Temperature Controlled, Sterile Pathology Class 1 864.3250 2026-04-16
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2024-04-05
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2024-05-10
LXZ Guard, Instrument General, Plastic Surgery Class 1 878.4800 2024-05-10
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2026-04-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-04-16

Official Correspondent

KOEN LUYPAERT

US Agent Details

Vicky Mucksavage Business: ALLWAYS FORWARDING INTL Email: vicky.mucksavage@shipallways.com Phone: (908) 3534000

Related Public Records

Same Entity

PALM MEDICAL INTERNATIONAL BV
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
K945777 Smiths Industries Medical Systems, Inc. PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES 1994-12-22
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
K092413 Inviro Medical Devices, Inc. INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES 2009-09-04
K163162 Jiangxi Hongda Medical Equipment Group , Ltd. Sterile Hypodermic Safety Syringes for Single Use 2017-03-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030626857. Last updated year: 2026. Please use registration number 3030626857 when referencing this establishment in official correspondence.
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