COMEPSA LTD

FDA Device Registration & Listing · Chiasso Ticino, CH · Registration 3009328501

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
3009328501
FEI Number
3009328501
Entity Name
COMEPSA LTD
City/State/Country
Chiasso Ticino, CH
Establishment Address
Via Livio 24, Chiasso Ticino 6830, CH
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
COMEPSA LTD (Owner Number: 10080291)
Owner / Operator Contact Address
Via Livio 24, Chiasso, CH-NOTA 6830, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K960787
PMA Number
N/A

All Registered Proprietary Names

GREINER-NEEDLE,HYPODERMIC, SAFETY INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2026-05-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-04-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-09-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-04-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-04-05
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-09-27
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-03-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-04-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-04-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-03-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-10-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-11-28
OCR Lung Sound Monitor Cardiovascular Class 2 870.1875 2026-01-22
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2023-09-13
HRX Arthroscope Orthopedic Class 2 888.1100 2023-09-13

Official Correspondent

Marco Maghetti

US Agent Details

Joe Pobdela Business: Jet Air Service Email: jpodbela@jafgl.com Phone: (718) 6567430

Related Public Records

Same Entity

COMEPSA LTD
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
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009328501. Last updated year: 2026. Please use registration number 3009328501 when referencing this establishment in official correspondence.
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