BMMEDICAL

FDA Device Registration & Listing · Lelystad Flevoland, NL · Registration 3031233007

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
3031233007
FEI Number
3031233007
Entity Name
BMMEDICAL
City/State/Country
Lelystad Flevoland, NL
Establishment Address
Charles Lindberghlaan 8, Lelystad Flevoland 8218 NS, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
BMmedical (Owner Number: 10090850)
Owner / Operator Contact Address
Charles Lindberghlaan 8, Lelystad, NL-FL 8218 NS, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K900652
PMA Number
N/A

All Registered Proprietary Names

Tape Tracheostomy tube Syringe Condenser Ostomy Tubes and vials Tubes and vials system Intravascular catheter Bandages Tracheostomy tube Needles Wound dressing Set Intravascular Container Cardiovascular Intravascular Set Surgical drape Wound dressing Tracheostomy Tube Tubes, Serum separators Spirometer Set Hypodermic Needle Catheter ANESTHESIOLOGY Cardiovascular Adaptor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2024-08-22
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2025-05-22
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2024-08-22
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2025-01-03
EXD Irrigator, Ostomy Gastroenterology, Urology Class 2 876.5895 2024-07-22
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-05-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-05-22
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-06-17
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-08-22
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2024-07-18
FQM Bandage, Elastic General Hospital Class 1 880.5075 2024-07-18
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2026-01-05
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-06-17
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-06-17
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-06-17
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2024-07-18
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2024-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-12-15
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2024-07-18
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2024-12-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-09-22
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2024-08-22
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2024-07-18
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2025-12-15
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-07-17
BWF Spirometer, Therapeutic (Incentive) Anesthesiology Class 2 868.5690 2025-05-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-08-22
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-09-13
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-07-17
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2025-05-22
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2024-12-10

Official Correspondent

Safina Beni

US Agent Details

Shawn Barnes Business: Allways Forwarding Email: shawn.barnes@shipallways.com Phone: (908) 3534000

Related Public Records

Same Entity

BMmedical
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
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K142298 Covidien Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff 2015-02-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0044-2017 Teleflex Medical 2
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
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-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031233007. Last updated year: 2026. Please use registration number 3031233007 when referencing this establishment in official correspondence.
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