Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1646831

FEI Number

1000160215

Entity Name

BIOMERICS FMI

City/State/Country

Athens, TX, US

Establishment Address

1605/1704/1700 Enterprise St., Athens, TX 75751, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biomerics FMI (Owner Number: 9008904)

Owner / Operator Contact Address

1605/1704/1700 ENTERPRISE ST., --, Athens, TX 75751, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vida PTV Dilatation Catheter Access Sheath Vensure Balloon dilation system catheter, angioplasty, peripheral, transluminal Cascade ureteral stent Proxis Ureteral Access Sheath Atlas Gold PTA Dilation Catheter Dual Lumen Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-01-16
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2013-01-16
OMZ	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter	Cardiovascular	Class 2	870.1250	2014-11-21
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-01-16
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2020-06-10
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2020-06-10
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2013-01-16
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2013-01-16
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-03-31
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2013-01-16
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2013-01-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-01-16
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2024-04-11
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2024-04-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-01-16
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2013-01-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-12-10
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2018-12-10
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2020-06-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-01-16
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2016-04-29
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2013-01-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-02-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2022-05-10
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2022-05-10
OMZ	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter	Cardiovascular	Class 2	870.1250	2022-05-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-05-10
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2015-12-04
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2013-12-05
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2013-12-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-01-16
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2019-08-30

Official Correspondent

STACEY LYONS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biomerics FMI

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
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07
K171251	Creagh Medical	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2017-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0012-2023	Hobbs Medical, Inc.	2	Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412
Z-0037-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Z-0038-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Z-0039-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1646831. Last updated year: 2026. Please use registration number 1646831 when referencing this establishment in official correspondence.