Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043467

FEI Number

3002855321

Entity Name

CHARMANT, INC.

City/State/Country

SABAE-CITY, FUKUI-PREF., JP

Establishment Address

6-1,KAWASARI-CHO, SABAE-CITY, FUKUI-PREF. 916-8555, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CHARMANT, INC. (Owner Number: 9001784)

Owner / Operator Contact Address

6-5 KAWASARI-CHO, --, SABAE-CITY, FUKUI-PREF, JP-NOTA 916, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fukushima Charmant Eddie Bauer Isaac Mizrahi Elle Charmant Charmant Charmant Charmant Charmant Charmant Charmant Charmant Charmant Fukushima Charmant Charmant Charmant Charmant Charmant Charmant Charmant Charmant ARISTAR Eddie Bauer Isaac Mizrahi Minamoto Esprit Aristar Charmant Titanium Line Art Z-Titanium Elle Ad-Lib Charmant Fukushima

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-08-10
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2022-11-23
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-08-28
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-08-18
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2016-01-20
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-05-14
HOH	Spectacle, Operating (Loupe), Ophthalmic	Ophthalmic	Class 1	886.4770	2021-07-16
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-09-24
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-08-17
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2018-07-18
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2019-05-28
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2014-06-02
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2025-04-02
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2015-01-22
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-06-25
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2015-01-23
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-08-18
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-08-18
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2015-02-16
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2018-04-02
HBM	Headrest, Neurosurgical	Neurology	Class 1	882.4440	2020-02-18
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1999-09-03
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-06-06
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2014-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

Douglas Fryer Business: Charmant USA Email: dfryer@charmant.com Phone: (973) 5381511

Related Public Records

Same Entity

CHARMANT, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2248180	CHARMANT U.S.A.	Morris Plains, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
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.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number	Establishment Name	Location
8010298	RUDOLF MEDICAL GMBH + CO. KG	FRIDINGEN Baden-Wurttemberg, DE
8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
8040373	NADEEM SURGICAL CORP. PRIVATE LTD.	SIALKOT Punjab, PK
2531475	URAMIX, INC.	E Lansdowne, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043467. Last updated year: 2026. Please use registration number 8043467 when referencing this establishment in official correspondence.