MedtechSourcebook

BIOMERICS Advanced Catheter

Contract manufacturer ยท Brooklyn Park, MN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2015Product codes first listed, by year (tallest: 5)2026
FDA registration
3012159165 (openFDA record; or search FDA's registration database)
FEI number
3012159165
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
Biomerics (FDA owner/operator no. 10042380)
Registered address
10351 Xylon Avenue N, Brooklyn Park, MN 55445
Contract listings
7 device listings, 7 product codes, first listed Nov 5, 2015
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
DQOCatheter, Intravascular, DiagnosticClass IICardiovascularContract manufacturingJun 24, 2020
DQXWire, Guide, CatheterClass IICardiovascularContract manufacturingJul 27, 2023
DQYCatheter, PercutaneousClass IICardiovascularContract manufacturingJun 24, 2020
KLAMonitor, Esophageal Motility, Anorectal Motility, And TubeClass IIGastroenterology and urologyContract manufacturingNov 5, 2015
MJNCatheter, Intravascular Occluding, TemporaryClass IICardiovascularContract manufacturingJun 24, 2020
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorClass IIGeneral and plastic surgeryContract manufacturingJun 24, 2020
PNOCatheter, Percutaneous, Cutting/ScoringClass IICardiovascularContract manufacturingFeb 25, 2020

Other contract facilities of Biomerics