Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043619925

FEI Number

3043619925

Entity Name

ASOMEDICA CO. LTD

City/State/Country

Smolevichi District Minsk, BY

Establishment Address

Great Stone China Belarus Industrial Park, Sapfirovaya St., 22, Smolevichi District Minsk 222210, BY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Asomedica Co. Ltd (Owner Number: 10095162)

Owner / Operator Contact Address

Great Stone China Belarus Industrial Park, Sapfirovaya St., 22, Smolevichi District, BY-HM 222210, BY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SILICONE DRAINAGE TUBE DRAINAGE TUBE CONNECTING CATHETER TUBE IN A COIL universal plugs Male plugs Female plugs ESMARCH'S MEDICAL MUGS SINGLE-USE LARYNGEAL MASK OXYGEN MASK foot urine collectors bedside urine collectors BREATHING MASK SUCTION CATHETER WITH VACUUM CONTROL OXYGEN CATHETER SUCTION CATHETER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-01-30
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-01-30
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2026-01-30
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2026-01-30
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2026-01-30
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2026-02-05
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2026-01-30
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2026-01-30
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2026-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 2545756

Related Public Records

Same Entity

Asomedica Co. 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

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3011137372	Teleflex Medical LLC	Morrisville, NC, US
3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK
3006673317	Conod Medical Co.,Limited	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043619925. Last updated year: 2026. Please use registration number 3043619925 when referencing this establishment in official correspondence.