FDA Device Registration & Listing · Buggenhout Oost-Vlaanderen, BE · Registration 3030626857
Normalized identity and public registration information from FDA records.
| 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 |
| 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 |
| 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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3024537844 | AVIA VASCULAR | Salt Lake City, UT, US |
| 3006285950 | Labcorp CLS | Indianapolis, IN, US |
| 1036836 | Sterigenics U.S., LLC | Haw River, NC, US |
| 1423507 | CAREFUSION 2200, INC. | Vernon Hills, IL, US |
| 3013557562 | CBR ENTERPRISE LIMITED | Hong Kong, HK |
3030626857 when referencing this establishment in official correspondence.