Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003213883

FEI Number

3003213883

Entity Name

BOMIMED INC.

City/State/Country

WINNIPEG, Manitoba, CA

Establishment Address

1-100 IRENE STREET, WINNIPEG, Manitoba R3T 4E1, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BOMIMED INC. (Owner Number: 9071838)

Owner / Operator Contact Address

1-100 IRENE STREET, --, WINNIPEG, MANITOBA, CA-MB R3T 4E1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BOMIMED LARYNGOSCOPES & HANDLES Breathing circuit set, coaxial, single use, adult/pediatric PN 260128, PN 260167, PN 260168, PN 260087

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2005-03-29
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2005-08-18
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2005-08-18

Official Correspondent

No official correspondent registered.

US Agent Details

Katie Doane Email: katie@fdabasics.com Phone: (716) 2208726

Related Public Records

Same Entity

BOMIMED INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

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9681384	Covidien	Ciudad Juarez Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003213883. Last updated year: 2026. Please use registration number 3003213883 when referencing this establishment in official correspondence.