Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023102955

FEI Number

3023102955

Entity Name

CHG-MERIDIAN CANADA LTD

City/State/Country

Mississauga Ontario, CA

Establishment Address

1 Robert Speck Parkway, Suite No. 960, Mississauga Ontario L4Z 3M3, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

CHG-MERIDIAN CANADA LTD (Owner Number: 10085392)

Owner / Operator Contact Address

1 Robert Speck Parkway, Suite No. 960, Mississauga, CA-ON L4Z 2G5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112680

PMA Number

N/A

All Registered Proprietary Names

Scope Broncho Video Scope Cysto Battery Fiberoptic Scope Cysto Videoscope Scope Rhino Fiberoptic Scope Colono Video Scope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2022-06-14
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-06-14
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2022-06-14
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2022-06-14
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2022-06-14
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-06-14
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2022-06-14
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2022-06-14
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2022-06-14
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2022-06-14
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-06-14

Official Correspondent

Ken Berger

US Agent Details

Ken Berger Business: CHG-MERIDIAN USA Corp. Email: ken.berger@chg-meridian.com Phone: (818) 7021800

Related Public Records

Same Entity

CHG-MERIDIAN CANADA 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
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0001-2016	US Endoscopy Group Inc	2	Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.

Similar Registrations

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3033902430	OMEC THAI CO.,LTD.	Bang Bo District Samut Prakan, TH
3002808148	SHIRAKAWA OLYMPUS CO., LTD.	NISHISHIRAKAWA-GUN Fukushima, JP
2936485	STRYKER ENDOSCOPY	SAN JOSE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023102955. Last updated year: 2026. Please use registration number 3023102955 when referencing this establishment in official correspondence.